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  • Medical Devices | CEHTRA

    Medical Devices As a legal manufacturer of Medical Devices or as a Supplier of components for Medical Device manufacturing, you may face unexpected challenges in applying the new quality and regulatory requirements. With over 20 years of combined experience, our passionate team has extensive knowledge in all aspects that will help you succeed in your market access strategy. As your secure and reliable partner, Cehtra provides a comprehensive service. We apply a tailored benefit/risk approach relevant to your product categorization and class. Our expertise includes Devices without an intended purpose, borderline products, combination products containing blood derivative, animal tissue, ancillary medicinal substance. Meet our expert Gaëlle REGUER Head of Medical Devices gaelle.reguer@cehtra.com Key Services Regulatory Affairs Support Quality Support Product- focused Manufacturing process-focused to ensure Business Performance through the whole lifecycle of technical files, from initiation to MDR/IVDR remediation to ensure Regulatory compliance based on the ISO 13485 requirements to ensure user-oriented Safety and Performance of the Medical Devices to ensure consistent Quality of Products which are made available to the market Regulatory Affairs support to ensure Business Performance through the whole lifecycle of technical files, from initiation to MDR/IVDR remediation Strategic approach of new markets Implementation of new requirements: EU MDR: Technical files: compliance with multiple requirements Risk Management file: whole lifecycle, whole processes Standard management: technical watch, implementation in Essential Requirements Comprehensive MD Vigilance ​ Quality support to ensure Regulatory compliance based on the ISO 13485 requirements ISO 13485, ISO 17025, FDA 21 CFR part 820, RCD 16 Audits: Internal & Suppliers/CMO/CRO Process: Creation, implementation, maintenance & reporting, risk-based approach Documentation: implementation, improvement for clarity & simplification CAPA: management at department levels Audit: technical management ​ Product-focused to ensure user-oriented Safety and Performance of the Medical Devices Preclinical Affairs: Risk assessment and control, toxicological risk assessment with skilled toxicologists Clinical Affairs: Clinical Evaluation Reports, Clinical evaluation of CAPA/Complaints Clinical Trials: regulatory support of Clinical trials Design transfer: From Product Specifications to Manufacturing Process Manufacturing Process-focused to ensure consistent Quality of Products which are made available to the market Qualification & Validation strategies consistent with production requirements, training and documentation Qualification : Equipment & Software / process validation & verification Risk based approach Qualification & Validation Output for Quality Assurance Documentation: implementation, improvement for clarity & simplification for regulatory purpose Value-added Services Holistic and transversal approach Data and bibliographic analysis for Biological Safety & Clinical Safety and Performance Training : Regulatory Affairs, Biological Safety Expert review of Technical Files Responsible Person for Regulatory Compliance Benefit/risk Evaluation Downloads Medical Devices Flyer - EN Key Contact Gaëlle REGUER Head of Medical Devices gaelle.reguer@cehtra.com Related Sectors Trainings

  • News & Events | CEHTRA

    Latest News To help you find the most relevant news, we have introduced a filter below. Select the markets that interests you. Stay informed about all our latest announcements across all our business sectors. This page will be updated regularly. Filter news for sectors that interests you - - - - - - - - - - All (Default) Biocides Global Notifications Pharmaceuticals Chemicals (REACH) Industrial Hygiene Plant Protection Cosmetics Packaging REACH Authorisation - IUCLID dossier will be soon required for all new active substance applications 14 / 11 / 2020 Posted on: In the framework of the implementation of the EC General Food Law and the Transparency Regulation, a IUCLID dossier will have to be submitted for every new active substance application from March 27th, 2021, and later in 2021 for renewal submissions. However, the CADDY dossier may not be immediately withdrawn and could still be required by some Member States. Therefore, applicants may be compelled to submit both IUCLID and CADDY dossiers. CEHTRA has a long experience with both software systems: CADDY for the PPP regulation and IUCLID for REACh and Biocides regulations. Moreover, we can help you for the whole registration process, from data gap analysis to the final dossier submission and beyond, including IUCLID and CADDY dossiers. Cyril DUROU from CEHTRA will be presenting at an upcoming Chemical Watch event on Biocides Posted on: 11 / 11 / 2020 Are you attending the Chemical Watch event on Borderlines of the Biocidal Products Regulation (BPR) with other legislation on 18th November? Our Biocides expert and Executive Vice President Cyril Durou is one of the speakers at this event. His presentation will be focused on Regulatory overview between biocidal products, veterinary borderline products and veterinary medicines. Please click on this link to have further information about this event: https://events.chemicalwatch.com/178479/borderlines-of-the-biocidal-products-regulation-bpr-with-other-legislation CEHTRA attending the Annual Biocontrol Industry Meeting 2020 Posted on: 17 / 10 / 2020 Blandine Journel and Sylviane Gony from CEHTRA will be attending ABIM - Annual Biocontrol Industry Meeting, 19-21 October 2020 (ABIM 2020 – The virtual conference and exhibition). If you are attending this event, Blandine and Sylviane will be happy to answer any questions you may have regarding Plant Protection services at CEHTRA. Feel free to get in touch with them! Introducing QuAC consortium 1 / 7 / 2020 Posted on: Introducing QuAC consortium – one umbrella to cover all Quaternary Ammonium Compounds. If your company has interest in biocidal products containing QUATS (including specific ones as well as combinations of QUATs), this consortium is for you. Together, CEHTRA and Steptoe & Johnson LLP offer a unique combination of in-depth expertise and understanding of the regulatory and legal requirements to provide seamless support and maximise value for all consortium members. Besides cost reduction, this umbrella consortium will will provide answer to all your interests for QUATs. Interested to know more? Attend one of our upcoming QuAC webinars where the team will present key aspects of this consortium – QuAC concept, strategy and costs. To register your interest, please get in touch with CEHTRA experts Nathalie Hanon, Cyril Durou and Annekathrin Faupel and Eléonore Mullier from Steptoe & Johnson LLP. Introducing 1bCoF consortium Posted on: 8 / 6 / 2020 1bCoF (stands for 1 biocides Co-Formulant) – first reliable Co-Formulants tool that belongs to Biocides community. 1bCoF is the first consortium with a digital touch where Biocides experts and companies can reliably and securely contribute, share and access valuable information on co-formulants. Check out more details on 1bCoF consortium on our Biocides page. If you are interested to join one of our interactive webinars on 1bCoF, please contact our Biocides experts Nathalie HANON, Cyril DUROU and Annekathrin FAUPEL to be added to the list of webinar attendees. CEHTRA Training: Sécurité des produits cosmétiques Posted on: 7 / 6 / 2020 CEHTRA propose une journée de formation consacrée à la sécurité des produits cosmétiques, le 17 septembre 2020, à distance. La formation rappellera les obligations règlementaires pour les produits cosmétiques et abordera celles qui sont spécifiques aux matières premières. Elle traitera de tous les sujets utiles à une bonne gestion de la sécurité du produit : données documentaires, tests in vitro et cliniques, profils toxicologiques, calculs de MOS, impuretés, CMR, perturbateurs endocriniens, cosmétovigilance… Des exemples pratiques illustreront toutes les notions théoriques. CEHTRA attends SETAC SciCon meeting 2020 7 / 6 / 2020 Posted on: Cyril Durou from CEHTRA will be presenting a poster today at the SETAC SciCon meeting on Co-formulants of biocidal products under the biocide regulation: challenges and perspectives. If you are attending this conference, do not hesitate to take a look at our poster. Cyril Durou will be happy to answer your questions. ​ CEHTRA is also one of the exhibitors at this meeting, so if you have any questions for us, our booth representatives Cyril Durou, Estelle Beltran and Pauline REMUZAT will be happy to help. CEHTRA gets a new logo and motto Posted on: 6 / 6 / 2020 For many of us, these past weeks were about adaptation, change and hope. As we are stepping into the world after, CEHTRA team thanks you for your continued trust. Your specialty products are unique on their markets. Our expertise is our mark of recognition. Hand in hand, Your Specialties and Our Expertise, can contribute to a better and a safer tomorrow. And guess what, this is also our new motto! Your Specialties, Our Expertise That comes with a new logo to emphasize our enhanced value proposition! Chemical Watch Biocides Symposium Posted on: 31 / 5 / 2020 Are you attending the Chemical Watch Biocides Symposium this week? Eléonore Mullier from Steptoe & Johnson LLP, Nathalie Hanon from CEHTRA and Gerard McElwee from Fieldfisher will be presenting a talk on Industry Covid-19 mobilisation: Disinfectant Practical Guide on 28th May at 13:45 CEST. CEHTRA is contributing to the on-going efforts in fighting COVID-19. 29 / 5 / 2020 Posted on: CEHTRA is contributing to the on-going efforts in fighting COVID-19. To help ensuring a rapid availability of disinfectants across the EU during COVID-19 pandemic, a Practical Guide on Fast-Tracking the Supply of Disinfectants has recently been published with the initiative of AISE International Association for Soaps, Detergents and Maintenance Products, EBPF (the European Biocidal Products Forum) and FECC (the European Association of Chemical Distributors) with voluntary contributions from Fieldfisher Belgium, Steptoe & Johnson LLP and CEHTRA. The version 1.2 of this guide was made available on the 27th April. Got questions? Our Biocides expert Nathalie Hanon will be happy to provide more details. News 11 Posted on: Date 11 Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. News 12 Posted on: Date 12 Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. News 13 Date 13 Posted on: Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. News 14 Posted on: Date 14 Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. News 15 Posted on: Date 15 Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. News 16 Date 16 Posted on: Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. News 17 Posted on: Date 17 Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. News 18 Posted on: Date 18 Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. News 19 Date 19 Posted on: Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. News 20 Posted on: Date 20 Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. News 21 Posted on: Date 21 Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. News 22 Date 22 Posted on: Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. News 23 Posted on: Date 23 Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. News 24 Posted on: Date 24 Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. News 25 Date 25 Posted on: Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. 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  • CEHTRAcker | CEHTRA

    Welcome to CEHTRA cker CEHTRA's window to worldwide regulatory support CEHTRAcker Interactive Map ​ Select a country in the map below to see how CEHTRA can accompany you ​ Locations in green indicate presence of CEHTRA offices Locations in blue indicate services available via CEHTRA's trusted partners Australia UK dfdfdfdfdf Reported introduction Assessed introduction (Health focus) Assessed introduction (Environment focus) Assessed introduction (Health & Environment focus) Go back to the interactive map Canada UK dfdfdfdfdf SCHEDULE 1 / R&D; Contained site-limited intermediate; Contained export-only SCHEDULE 4 / not on NDSL (> 100 kg) or on NDSL (> 1T) SCHEDULE 5 / not on NDSL (1-10T) or on NDSL (> 10T) SCHEDULE 6 / not on NDSL (> 10T) Go back to the interactive map China UK dfdfdfdfdf Record Notification - MEE Order No. 12 Simplified Registration - MEE Order No. 12 Regular Registration - MEE Order No. 12 Go back to the interactive map European Union UK dfdfdfdfdf 1-10 tpa 10-100 tpa 100-1000 tpa > 1000 tpa Go back to the interactive map Japan UK dfdfdfdfdf Small Volume Permit (SVP) < 1 t/a Low volume Exemption (LVE) < 10 t/a & not bioaccumulative Full notification > 10 t/a Go back to the interactive map Philippines UK dfdfdfdfdf Small Quantity Importation (SQI) Abbreviated form Detailed Form Go back to the interactive map South Korea UK dfdfdfdfdf 0.1 - 1 tpa 1-10 tpa 10-100 tpa 100-1000 tpa > 1000 tpa Go back to the interactive map Turkey UK dfdfdfdfdf 0.1 - 1 tpa 1-10 tpa 10-100 tpa 100-1000 tpa > 1000 tpa Go back to the interactive map United Kingdom UK dfdfdfdfdf Click here to get redirected to our page dedicated to Brexit Go back to the interactive map USA UK dfdfdfdfdf US EPA Pre-Manufacture Notification (PMN) US EPA Low volume Exemption (LVE) Go back to the interactive map

  • Plant Protection | CEHTRA

    Plant Protection As a manufacturer or a distributor in the field of agriculture, you want to get your substances approved efficiently and get your Plant Protection Products on the market. From Data Gap Analysis through to the dossier submission to the competent authorities, CEHTRA's team supports you in the necessary steps to meet the current regulatory requirements, for a successful registration. Meet our experts Philippe ADRIAN Head of Plant Protection philippe.adrian@cehtra.com Estelle BELTRAN Expert Environmental Consultant estelle.beltran@cehtra.com Blandine JOURNEL Senior Ecotoxicologist blandine.journel@cehtra.com Key Services Regulatory Dossiers From registration strategy up to the post-submission defense Data Gap Analysis Testing proposal, study monitoring, hazard identification, scientific rationale Risk Assessment Toxicology, Consumer, Environment, Ecotox, modelling and refinement Task Force Management Management support to facilitate joint applications in the EU and abroad Value-added services Endocrine Disrupting Properties CADDY and IUCLID dossiers Tailored studies (operator, field) for regulatory compliance Fertilizers and Biostimulants Environmental Screening Authorization of formulated products (including North and South America) Downloads Plant Protection Flyer - EN Key Contacts Philippe ADRIAN Head of Plant Protection philippe.adrian@cehtra.com Estelle BELTRAN Expert Environmental Consultant estelle.beltran@cehtra.com Blandine JOURNEL Senior Ecotoxicologist blandine.journel@cehtra.com Related Sectors Trainings

  • Brexit | CEHTRA

    Brexit The Brexit transition deadline of 31 December 2020 is fast approaching and it is vital that companies ensure that they remain compliant beyond this date. CEHTRA team remains available to answer any queries you may have to ensure you are compliant with the new regulatory framework which will apply from 1st January 2021. We have addressed some key information related to three of key business sectors (REACH, Biocides and Plant Protection) on this page to keep you informed how CEHTRA experts can accompany you with the new regulatory framework. Key Contacts Biocides Annekathrin FAUPEL Regulatory Affairs Specialist annekathrin.faupel@cehtra.com REACH Plant Protection Melanie HARPER Regulatory Affairs Specialist melanie.harper@cehtra.com Philippe ADRIAN Head of Plant Protection philippe.adrian@cehtra.com REACH UK REACH Registration and OR UK REACH OR Consortium Management Support for negotiation with data holders for access Communications with UK regulatory authorities Biocides Plant Protection Great Britain (England, Scotland and Wales) will establish independent pesticides regulatory rules on 1 January 2021. Therefore please make sure that your current UK products are authorised under the new rules. ​ According to CRD, the new laws to ensure the safe use of plant protection products will be similar to existing laws including compliance with regulations for Maximum Residue Levels (MRLs). ​ Current product authorisations and MRLs will still be valid in the Great Britain from 1 January 2021. The Health and Safety Executive (HSE) will continue to operate as the UK’s regulator. In addition, under the terms of the Northern Ireland Protocol, the EU pesticides rules will continue to apply in Northern Ireland after 1 January 2021. ​ CEHTRA will continue to support its clients for their UK products. REACH UK REACH Registration UK REACH OR Consortium Management Support for negotiation with data holders for access Communications with UK regulatory authorities Biocides UK BPR OR (Article 95) UK BPR Registration UK BPR Authorisation From 1 January 2021, Great Britain (England, Scotland and Wales) will put in place a regulatory framework for biocidal products. It will be similar to EU framework (EU BPR), but both will operate independently of each other. ​ All applications will be submitted to HSE as regulating authority Biocidal product authorizations and active substance approvals that are valid in GB will remain valid until their normal expiry date. The authorization will need to be transferred to a company based in UK. The authorization holder of biocidal actives and products will need to be established in the UK by 1st January 2022. Respective data might have to be resubmitted to HSE. These data will be the same data or other information that you previously submitted to ECHA or other competent authorities. Biocidal product or active substance applications still under evaluation after 31st December 2020 will be continued by HSE where possible to grant the authorization. Information supporting the original application has to be resubmitted for enabling HSE to complete the evaluation within 90 or 180 days depending on your situation. ​ A UK article 95 list for approved a.s. suppliers will be established similar to the EU Article 95 list. To stay on the UK Article 95 list you will have to comply with the according requirements within 2 years’ time. Plant Protection Great Britain (England, Scotland and Wales) will establish independent pesticides regulatory rules on 1 January 2021. Therefore please make sure that your current UK products are authorised under the new rules. ​ According to CRD, the new laws to ensure the safe use of plant protection products will be similar to existing laws including compliance with regulations for Maximum Residue Levels (MRLs). ​ Current product authorisations and MRLs will still be valid in the Great Britain from 1 January 2021. The Health and Safety Executive (HSE) will continue to operate as the UK’s regulator. In addition, under the terms of the Northern Ireland Protocol, the EU pesticides rules will continue to apply in Northern Ireland after 1 January 2021. ​ CEHTRA will continue to support its clients for their UK products.

  • Internships damaged | CEHTRA

    Internships CEHTRA is always looking to recruit new interns that can add strength and depth to our existing staff and contribute to the growth of the company. Would you like to join this friendly yet consciencious and professional group? ​ If you think that you have the right attributes, such as scientific competence, innovative mind-set and strong work ethic then send us a copy of your CV: recruitment@cehtra.com

  • Upcoming Events | CEHTRA

    Upcoming Events This page will be regularly updated with events and conferences attended by CEHTRA experts. We also have an exhibition booth at some selected events which are excellent occasions to meet and discuss with our team. News A Title News A date Posted on: Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Click here for more information News B Title Posted on: News B date Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Click here for more information News C Title Posted on: News C date Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Click here for more information

  • Query Form | CEHTRA

    Query Form If you have questions, feel free to get in touch with our team by filling in the query form below. Select a sector Your name Your email address Company / Organization Your job title Your message General Query Biocides Cosmetics Chemicals (REACH) Global Notifications Industrial Hygiene Packaging Pharmaceuticals Plant Protection REACH Authorization arrow&v Submit Thank you for your message. We will contact you at the earliest possible.

  • Key Contacts | CEHTRA

    Key Contacts Section 1: Key Business Sectors Sector Contact person Job title Email address Biocides Biocides Biocides Nathalie HANON Cyril DUROU Annekathrin FAUPEL Head of Biocides Senior Ecotoxicologist Senior Regulatory Manager Chemicals (REACH) Chemicals (REACH) Chemicals (REACH) Mathieu ROLLAND Aurelie SEVESTRE Brigitte CASENAVE Head of Chemicals (REACH) Senior Toxicologist Senior Chemist Cosmetics Clarisse BAVOUX Head of Cosmetics Global Notifications Global Notifications Global Notifications Aurelie SEVESTRE Damien GUYOMAR Melanie HARPER Head of Global Notifications Toxicologist Regualtory Affairs Specialist Industrial Hygiene Charles ALARCON Head of Industrial Hygiene nathalie.hanon@cehtra.com cyril.durou@cehtra.com annekathrin.faupel@cehtra.com mathieu.rolland@cehtra.com aurelie.sevestre@cehtra.com brigitte.casenave@cehtra.com clarisse.bavoux@cehtra.com aurelie.sevestre@cehtra.com damien.guyomar@cehtra.com melanie.harper@cehtra.com charles.alarcon@cehtra.com Packaging Francois RENON Head of Packaging francois.renon@cehtra.com Pharmaceuticals Pharmaceuticals Pharmaecuticals Stephane PIERRE Maryse CORROLLER Blandine JOURNEL Head of Pharmaceuticals Expert Toxicologist Senior Ecotoxicologist stephane.pierre@cehtra.com maryse.corroller@cehtra.com blandine.journel@cehtra.com Plant Protection Plant Protection Plant Protection Philippe ADRIAN Estelle BELTRAN Blandine JOURNEL Head of Plant Protection philippe.adrian@cehtra.com Expert Environmental Consultant estelle.beltran@cehtra.com Senior Ecotoxicologist blandine.journel@cehtra.com REACH Authorisation Stephane PIERRE Head of REACH Authorisation stephane.pierre@cehtra.com Medical Devices Gaëlle REGUER Head of Medical Devices gaelle.reguer@cehtra.com Section 2: Our International contact points ​ Country France France France Contact person Cyril DUROU Sarah TERRADOT Stephane PIERRE Agency Cenon agency Lyon agency Paris agency Belgium Philippe ADRIAN Brussels agency Canada Jason NUGENT Toronto agency India India Pramod KUMAR Kaleeswaran SAMPATH New Delhi agency Trivandrum agency Germany Annekathrin FAUPEL Stade agency Spain Nathalie HANON Madrid agency United Kingdom Peter JENKINSON Nottingham agency Email address cyril.durou@cehtra.com sarah.terradot@cehtra.com stephane.pierre@cehtra.com philippe.adrian@cehtra.com jason.nugent@cehtra.com pramod.kumar@cehtra.com kaleeswaran.sampath@cehtra.com annekathrin.faupel@cehtra.com nathalie.hanon@cehtra.com peter.jenkinson@cehtra.com

  • Cosmetics | CEHTRA

    Cosmetics Demonstrate the safety of both your finished products and ingredients. Get the packaging safety tested. Shorten the time to market. The current regulation for the cosmetics industry requires safety assessment to be performed by a qualified Safety Assessor, with a relevant expertise in Toxicology. Cosmetics Combining our years of expertise, information from our databases and access to state-of-the-art digital tools, we aim at demonstrating safety and compliance for cosmetic products in CPSR and PIF documents. During the R&D phase, before launching the product on the market and later, we anticipate concerns, validate safe uses and manage easy updates. Meet our experts Clarisse BAVOUX Head of Cosmetics clarisse.bavoux@cehtra.com Marlène BARON Toxicologist marlene.baron@cehtra.com Anna TAN-SÉPOT Toxicologist anna.tan-sepot@cehtra.com Key Services CPSR comprehensive evaluation Raw Materials: toxicity and maximal doses Ingredients under development: strategy, dossier Support for toxicological and eco-toxicological issues Pre-assessment and final Cosmetic Product Safety Report Toxicological Profiles and identification of safe concentrations for cosmetic uses Strategy for tests, in silico approach, complementary data and final dossier Literature search, use of existing data, in vitro tests and support for in silico approaches CEHTRA has been commissioned by numerous companies including multi-nationals in the cosmetics industry to assist them with cosmetic regulation compliance. CEHTRA evaluates the safety of several types of products (care, hygiene, perfumes...), and new ingredients. CEHTRA’s comprehensive databases allow us to anticipate risks for your products. We can propose complementary approaches in case of data gaps (structural alerts, QSAR, Read-across). Our eco-toxicologists can contribute to the eco-conceptions of your formula. ​ At CEHTRA, we are professional partner of the Cosmetic Valley and provide different training courses on the Fundamentals of the Cosmetic Regulation, webinars on Content / Container Interactions or seminaire in University. Value-added services In-depth expertise for INCIs, impurities and perfume components, including MOS and QRA In-house rich database Digital analysis of the impact of changes to manage the need of updates Review of Product Information files Responsibility of the Responsible Person for your products (through written mandate) International regulatory compliance Downloads Cosmetics Flyer - EN Key Contacts Clarisse BAVOUX Head of Cosmetics clarisse.bavoux@cehtra.com Marlene BARON Toxicologist marlene.baron@cehtra.com Anna TAN-SEPOT Toxicologist anna.tan-sepot@cehtra.com Related Sectors Packaging

  • Trainings | CEHTRA

    Trainings Trainings You choose what you want to learn and when. Regular training is essential to keep up-to-date with the changing regulations. You can come to us or we can come to you. Unique Tariff Price per participant: 1,100€ / day (excluding VAT) The price includes the training materials and lunch. ​ You choose when, You choose where Upon request, our courses can be customized to your specific requirements. ​ How to register? Pre-registration form to be sent to training@cehtra.com ​ Got questions? Please contact our Training Coordinator ​ Faizan SAHIGARA Training Coordinator training@cehtra.com Training 1 Duration: 1 day Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Click here for more details Training 2 Duration: 1 day Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Click here for more details Training 3 Duration: 1 day Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Click here for more details Training 4 Duration: 1 day Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat Click here for more details Training 5 Duration: 1 day Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Click here for more details Training 6 Duration: 1 day Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Click here for more details Training 7 Duration: 1 day Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. ​ Click here for more details Training 8 Duration: 1 day Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Click here for more details Training 9 Duration: 1 day Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. ​ Click here for more details Training 10 Duration: 1 day Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. ​ Click here for more details Training 11 Duration: 1.5 days Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Click here for more details Training 12 Duration: 1 day Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. ​ Click here for more details Training 13 Duration: 1 day Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. ​ Click here for more details Training 14 Duration: 1 day Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Click here for more details Training 15 Duration: 1 day Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. ​ Click here for more details Training 16 Duration: 1 day Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. ​ Click here for more details Training 17 Duration: 1 day Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Click here for more details Training 18 Duration: 1 day Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. ​ Click here for more details Training 19 Duration: 1 day Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. ​ Click here for more details Training 20 Duration: 1 day Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Click here for more details Training 21 Duration: 1 day Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. ​ Click here for more details Training 22 Duration: 1 day Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. ​ Click here for more details Training 23 Duration: 1 day Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Click here for more details Training 24 Duration: 1 day Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. ​ Click here for more details Training 25 Duration: 1 day Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. ​ Click here for more details

  • Pharmaceuticals | CEHTRA

    Pharmaceuticals (Human & Veterinary) For the safety of your pharmaceutical and veterinary substances & products CEHTRA can assist you with: Safety of your drug substances and drug products: development and regulatory submissions. Safety of your drug production (PDE, OEL/OEB, impurities qualification) Generation of Environmental Risk Assessment (ERA) for your MAA dossier (Directive 2004/27/EC) ​ ​ Meet our experts Stephane PIERRE Head of Pharmaceuticals stephane.pierre@cehtra.com Maryse CORROLLER Expert Toxicologist maryse.corroller@cehtra.com Blandine JOURNEL Senior Ecotoxicologist, ERA blandine.journel@cehtra.com Key Services PDE and OEL/OEB Calculations Safety assessment of drug production and workers on site (PDE, OEL/OEB) Safety Qualification of Impurities Safety qualification of impurities in drug substances or products (ICH and VICH guidelines) Preclinical Expertise Development plan, study monitoring, writing regulatory dossiers (CTA, MAA...) Environmental Risk Assessment All the ERA part of the MAA is done (dossier preparation, study monitoring, defense with authorities…) Value-added services Trainings QSAR support using Nexus DEREK and Leadscope Data and bibliographic analysis Toxicologist and Ecotoxicologist team (as well as QSAR expert) Dossier Defense Regulatory Watch Downloads Pharmaceuticals Flyer - EN Key Contacts Stephane PIERRE Head of Pharmaceuticals stephane.pierre@cehtra.com Maryse CORROLLER Expert Toxicologist maryse.corroller@cehtra.com Blandine JOURNEL Senior Ecotoxicologist, ERA blandine.journel@cehtra.com Related Sectors Cosmetics Biocides Chemicals (REACH) Industrial Hygiene Packaging

  • Dedicated Support (Régie) | CEHTRA

    Dedicated Support (Régie) Combining our high-skilled expertise (toxicology, expology, ecotoxicology, regulatory expertise, product stewardship) with our diverse business sectors (Biocides, Chemicals (REACH), Cosmetics, Global Chemical Notification, Industrial Hygiene, Medical devices, Packaging, Pharmaceuticals, Plant Protection), CEHTRA propose a Dedicated Support by outsourcing its team resources to its clients. In France, this outsourcing contract is known as Régie . Key Services Embedded staff Extended staff Our consultants work from our clients’ site Our consultants work from our offices but exclusively for our client Dedicated Support ; the contract can be as short as one month or it could be for a long-term, part time or full time. It can be extended as many times as needed. During this period, one or more of our experienced and trained consultants will either: maximizes flexibility for CEHTRA clients ​ a) work from our clients’ site and be integrated into their team ( ) Embedded staff b) work from our offices but exclusively for our client ( ) Extended staff ​ Value-added Services Support from CEHTRA experts Maximum flexibility with contract conditions ​ A key advantage of securing Dedicated Support with CEHTRA is the whichever the barriers : scientific, regulatory... experience and expertise provided by our senior and expert team members ​ Depending on the level of expertise required (junior, specialist or senior profile), duration (short or long term, part-time or full-time), we will adapt our pricing that best suits your needs and budget. Key Contact Our key contact for Dedicated Support, Stephane PIERRE will be happy to answer all your queries. You can either write him an email or simply drop your query into the chat window below. Interested to know more? Stephane PIERRE In charge of Dedicated Support / Régie stephane.pierre@cehtra.com

  • CEHTRA - Your Specialities Our Expertise | Consultancy based in France

    Your Specialties, Our Expertise CEHTRA stands for Consultancy for Environmental & Human Toxicology and Risk Assessment ​ Since 2001, we provide high quality scientific and innovative solutions ensuring regulatory compliance of chemicals to international obligations. ​ You are committed to the safety of your products. We are committed to high quality regulatory services at optimized costs. Our key business sectors Biocides Chemicals (REACH) Cosmetics Global Chemicals Notification Packaging Industrial Hygiene Medical Devices Pharmaceuticals Plant Protection REACH Authorisation Tools & Consortiums Already have a PRIMO account ? Click here New to PRIMO ? Click here New to 1BCoF ? Click here Our key services Technical assistance & Expert advice Dossier preparation and registration Only Representative services QSARs and Read-Across Expert advice on critical roadblocks Outsourcing & Régie Our consultant at your site or at CEHTRA offices, with full access to CEHTRA expertise, tools and managers. Full time/part time, dedicated to your needs. Training & Mentoring Wide catalog of regulatory and scientific trainings Bespoke trainings to best suit clients' needs Dedicated mentoring to meet your goals Latest News NewsA title NewsB time NewsB title NewsC time NewsC title NewsD time NewsD title NewsGC title CCCC Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. ​ Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Ertuei. NewsGD title DDDDD Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. NewsGB title BBBBB Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. NewsGA title AAAAA Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. ​ Click here for more news NewsA time

  • Data Privacy | CEHTRA

    Data Privacy GDPR is the General Data Protection Regulation, a sweeping legislation passed by the EU and enforceable as of May 25, 2018. GDPR maintains that data protection is a fundamental human right and it is the responsibility of any company that controls and processes data to protect that right. At some point over the past few years we have been in contact with you, either as part of a scientific and regulatory forum or in another capacity. You already know that we do not send out emails which are not tailored towards your specific needs or are not of mutual interest. We will not bombard you with endless e-mails that are of little interest to you, but every-so-often, there may be something that we think may be of interest to you for your business. ​ Your data: We collect only the data that is strictly necessary. This means your contact details. They are only used for communicating with you regarding business related matters. ​ Your data remains confidential: We promise to never transmit, share or reveal our personal data with any other entity, business or organisation for whatever means, in full compliance with the General Data Protection Regulation (GDPR) of 2018. ​ Your rights to access: In full compliance with the , you may at anytime access the your data in order to modify or update them by simply contacting us at: French CNIL CEHTRA SAS 15 rue Aristide Briand Cenon, Bordeaux France contact@cehtra.com ​ Your right to be forgotten: Your personal data is kept for a maximum of 5 years. You may at anytime request that your details be deleted. ​ Your data is secure: CEHTRA does everything that is possible to ensure that your data is safe. he data service provider OVH ensures that the site respects the legal requirements as described namely the General Data Protection Regulation (GDPR) of 2018. ​

  • Industrial Hygiene | CEHTRA

    Industrial Hygiene CEHTRA's industrial hygienists have decades of experience working with clients in their industrial sites and manage Environmental, Health and Safety challenges with a well balanced mix of technical expertise and practical experience. CEHTRA's track record in multi-disciplinary risk assessment and modelling applies well to real world situations involving chemical substances: ever since its creation, CEHTRA has designed and conducted EHS audits, and advised management at countless sites in virtually every sector of the chemical industry and services. Meet our experts Charles ALARCON Industrial Hygienist charles.alarcon@cehtra.com Key Services Exposure Scenarios Characterisation of the risk linked to the handling of the chemical agent Risk Management Measures Ensure compliance with eSDS requirements (Operating Conditions and Technical Measures) Safety Data Sheets Safety information on substances and mixtures from manufacture to use Chemical Safety Reports Refining approaches used in the CSR to guarantee safe use and worker protection Chemical agents are classified according to their hazard level. An inventory of the uses of the chemical agents feeds the exposure assessments via Exposure Scenarios, which enables the characteriation of the risk linked to the handling of the chemical agent. We base our evaluation on the Exposure Scenarios written in the Chemical Safety Report and the Safety Data Sheets that will accompany the chemical agent on the Downstream Users premises. Value-added services Advice on exposure and health risks Exposure scenarios using CHESAR and other tools Training modules for specific company needs Interpreting risk data Transport of Dangerous Goods by road (ADR2015) Defining right strategies for monitoring campaigns Downloads Industrial Hygiene Flyer - EN Key Contact Charles ALARCON Industrial Hygienist charles.alarcon@cehtra.com Related Sectors Chemicals (REACH) Global Notifications REACH Authorisation

  • Legal | CEHTRA

    Legal This website is hosted by WIX.com Inc. 500 Terry A François Blvd San Francisco, CA 94158, USA ​ ​ CEHTRA - Consultancy for Environmental & Human Toxicology and Risk Assessment ​ CEHTRA Company information CEHTRA SAS 15 rue Aristide Briand 33150 Cenon France Tel: +33 (0) 557 77 56 10 Fax: +33 (0) 557 77 56 20 contact@cehtra.com Reference : CEHTRA SAS Capital social : 16 000 € RCS Bordeaux 434 733 440 TVA FR 24 434 733 440 APE: 7490B SIRET: 434 733 440 00086 Web Hosting :ONLINE SAS B.P. 438 75366 Paris Cedex 08 www.online.net The following terms of use are applicable to the website www.cehtra.com. This website is designed for a French audience and/or people located in France however the terms of use applicable to other countries and regions around the world can vary. Website ​ The website is a company presentation site. www.cehtra.com ​ CEHTRA could never be held responsible for any direct or indirect damages, whatever the cause, origin or nature and consequence, ensued from the consult or use of the website. In particular, CEHTRA accepts no responsibility in case of an interruption or the inability to access the website, bugs, and any other damages arising from the fraudulent actions of third party from the website. Privacy policy - Personal data ​ All personal data collected on the site are treated with the strictest confidentiality. We remind you that you have a right of access, modification, correction and suppression of the data which concern you (art. 34 of the law "Informatique et Libertés" of January 6, 1978). To exercise this right, please contact us. CEHTRA SAS 15 rue Aristide Briand 33150 Cenon France Tel : +33 (0) 557 77 56 10 Fax : +33 (0) 557 77 56 20 contact@cehtra.com READ MORE ABOUT DATA PRIVACY Guarantees and responsibilities ​ CEHTRA endeavors to assure at best that the information at your disposal through the website is accurate and updated. However CEHTRA does not guarantee in any way that the information are accurate, complete and updated. CEHTRA does not insure any tacit or expressed guarantee regarding the whole or a part of the website. Intellectual property and right ​ The website are hosted by the company CEHTRA: ​ biocide-consulting.com cehtra.co.uk cehtra.com cehtra.eu cehtra.fr consulting-reach.com environment-consultancy.com net-reach.eu pesticide-consulting.com reach-chemical-consulting.com reach-expert.com toxicology-consultancy.com ​ The website is an intellectual creation and is under the intellectual property laws. The whole website and each of its components (texts, schemas, software, codes, photos, drawings, logos, brands and models) are the exclusive property of CEHTRA which is the only one empowered to use the relevant intellectual property rights. ​ ​ ​ Guarantees and responsibilities ​ CEHTRA endeavors to assure at best that the information at your disposal through the website is accurate and updated. However CEHTRA does not guarantee in any way that the information are accurate, complete and updated. CEHTRA does not insure any tacit or expressed guarantee regarding the whole or a part of the website. Disputes ​ The previous terms are stated according to the French right and in particular the measures of the law n°2004-575 of the 21st June 2004 for the trust in the digital economy and the lawi n°78-17 of the 6t January 1978 modified by the law n°2004-801 of the 6th August 2004 IT and Freedom. The jurisdictions Sainte Eulalie have the ability to know all the disputes regarding the website.

  • Packaging | CEHTRA

    Packaging Experienced, quality support in managing the complex and constantly evolving regulation on food and food packaging . Our food contact materials and packaging team has over a decade of hands-on experience providing worldwide regulatory support, can help you to ensure the safety of your products and can help you prepare and update your dossiers. Meet our expert Francois RENON Head of Packaging francois.renon@cehtra.com Key Services Food contact and packaging regulatory support FCS risk assessments Declaration of compliance Cosmetic Packaging: ICC Worldwide support to be compliant with the requirements of the food contact and packaging regulations Risk assessments of food contact substances to be compliant with the regulation For all the actors of the chain value (from the starting substances suppliers to the manufacturer of the final article) Risk assessment of the interactions between the container and the content of cosmetic products Risk Assessment of articles made from plastics, glass, paper & board, coatings, metals... Including recycled, biobased and biodegradable materials Pragmatic approach to avoid expensive migration or extraction tests Regulatory Support on worldwide food contact regulations including the EU Member States, Switzerland, USA, China, MERCOSUR... Toxicological Expertise Risk assessment of food contaminants Value-added services Data management for cosmetic packaging Support on enviromental legislation on packaging External resources Regulatory Watch Training support for the risk assessment of cosmetic packaging Training support for recycled packaging Downloads Packaging Flyer - EN Key Contacts Francois RENON Head of Packaging francois.renon@cehtra.com Related Sectors Cosmetics Industrial Hygiene

  • News | CEHTRA

    Latest News Text text text Text text text Text text text Text text text Text text text Text text text Text text text Text text text Text text text Text text text Text text text Text text text Text text text Text text text Text text text Text text text Text text text Text text text Events Text text text Text text text Text text text Text text text Text text text Text text text Text text text Text text text Text text text Text text text Text text text Text text text Text text text Text text text Text text text Text text text Text text text Text text text

  • PRIMO | CEHTRA

    Already have a PRIMO account? Click here Unlock the power of Cloud Technology to manage your Worldwide Registrations … Introducing A CEHTRA-designed tool dedicated to your regulatory compliance What is PRIMO? . PRIMO stands for Principle Regulatory Information Management Organizer PRIMO has been designed by our regulatory and IT experts to keep you up-to-date with regulatory compliance information for your projects. With its state-of-the-art cloud technology, PRIMO allows its users to: a) both share and store their data securely, b) prepare their worldwide registration dossiers and c) make project management easier by giving simultaneous access to all team members, external collaborators and consultants. Data Storage Secure sharing and storage of your data ✓ Easy document upload and download ✓ Working Documents Instant access for anyone, anytime, anywhere ✓ Data Gap Analysis (DGA) ✓ Country-specific support for DGA ✓ Monitoring follow-up ✓ Project Management Track work progress in real-time ✓ Project budget at your fingertips ✓ Two licence options PRIMO Basic PRIMO Ultimate to best suit your needs Basic Ultimate Client Access* Upload/download documents Create/modify registration dossiers Create tasks Track work progress (Gantt Chart) Access to country-specific DGA Access to country-specific support for DGA preparation Access to other clients' consultants Read-only ✓ Read/write ✓ ✓ ✓ Read-only Read-only ✓ Read/write Read/write ✓ ✓ * CEHTRA offers a free access to PRIMO Basic to all its clients. Downloads PRIMO advert Access PRIMO Already have a PRIMO account? Click here to access Have questions about PRIMO? Drop your queries to: contact@cehtra.com ​ or leave your messages on Let's Chat window below Latest Announcements Please visit this page regularly for all future updates on PRIMO

  • Sectors | CEHTRA

    Biocides Introduction in 5 lines. Introduction in 5 lines. Introduction in 5 lines. Introduction in 5 lines. Introduction in 5 lines. Introduction in 5 lines. Introduction in 5 lines. Introduction in 5 lines. Introduction in 5 lines. Introduction in 5 lines. Introduction in 5 lines. Introduction in 5 lines. Introduction in 5 lines. Introduction in 5 lines. Introduction in 5 lines. Meet our experts Nathalie HANON Head of Biocides nathalie.hanon@cehtra.com Cyril DUROU Senior Ecotoxicologist cyril.durou@cehtra.com Annekathrin FAUPEL Biocodes Regulatory Affairs annekathrin.faupel@cehtra.com Text line 1 Text line 1 Text line 1 Text line 1 Text line 1 Text line 1 Text line 1 Text line 1 Text line 1 Text line 1 Text line 1 Text line 1 Text line 1 Text line 1 Key Services Text text 3 lines max Text text Text to explain Key service 1 (4 lines max) text Text text 3 lines max Text text Text to explain Key service 1 (4 lines max) text Text text 3 lines max Text text Text to explain Key service 1 (4 lines max) text Text text 3 lines max Text text Text to explain Key service 1 (4 lines max) text Bullet point 1 Bullet point 1 Bullet point 1 Bullet point 1 Bullet point 1 Bullet point 2 Bullet point 2 Bullet point 2 Bullet point 2 Bullet point 2 Bullet point 3 Bullet point 3 Bullet point 3 Bullet point 3 Bullet point 3 Bullet point 4 Bullet point 3 Bullet point 3 Bullet point 3 Bullet point 4 Bullet point 5 Bullet point 3 Bullet point 3 Bullet point 3 Bullet point 5 Other Services Text text text text Text text text text Text text text text Text text text text Text text text text Text text text text Text text text text Text text text text text text text text text text text text text text text text text ​ ​ Text text text text Text text text text text text text text text text text text text text text text text ​ ​ Text text text text Text text text text text text text text text text text text text text text text text ​ ​ Text text text text Text text text text text text text text text text text text text text text text text Biocides Brochure - EN Biocides Brochure - FR Key Contacts Nathalie HANON Head of Biocides nathalie.hanon@cehtra.com Cyril DUROU Senior Ecotoxicologist cyril.durou@cehtra.com Annekathrin FAUPEL Biocodes Regulatory Affairs annekathrin.faupel@cehtra.com Relevant sectors and services Chemicals (REACH) Plant Protection

  • Latest News | CEHTRA

    Latest News Stay informed about all our latest announcements across all our business sectors. This page will be updated regularly. IUCLID dossier will be soon required for all new active substance applications 14 / 11 / 2020 Posted on: In the framework of the implementation of the EC General Food Law and the Transparency Regulation, a IUCLID dossier will have to be submitted for every new active substance application from March 27th, 2021, and later in 2021 for renewal submissions. However, the CADDY dossier may not be immediately withdrawn and could still be required by some Member States. Therefore, applicants may be compelled to submit both IUCLID and CADDY dossiers. CEHTRA has a long experience with both software systems: CADDY for the PPP regulation and IUCLID for REACh and Biocides regulations. Moreover, we can help you for the whole registration process, from data gap analysis to the final dossier submission and beyond, including IUCLID and CADDY dossiers. Cyril DUROU from CEHTRA will be presenting at an upcoming Chemical Watch event on Biocides Posted on: 11 / 11 / 2020 Are you attending the Chemical Watch event on Borderlines of the Biocidal Products Regulation (BPR) with other legislation on 18th November? Our Biocides expert and Executive Vice President Cyril Durou is one of the speakers at this event. His presentation will be focused on Regulatory overview between biocidal products, veterinary borderline products and veterinary medicines. Please click on this link to have further information about this event: https://events.chemicalwatch.com/178479/borderlines-of-the-biocidal-products-regulation-bpr-with-other-legislation CEHTRA attending the Annual Biocontrol Industry Meeting 2020 Posted on: 17 / 10 / 2020 Blandine Journel and Sylviane Gony from CEHTRA will be attending ABIM - Annual Biocontrol Industry Meeting, 19-21 October 2020 (ABIM 2020 – The virtual conference and exhibition). If you are attending this event, Blandine and Sylviane will be happy to answer any questions you may have regarding Plant Protection services at CEHTRA. Feel free to get in touch with them! Introducing QuAC consortium 1 / 7 / 2020 Posted on: Introducing QuAC consortium – one umbrella to cover all Quaternary Ammonium Compounds. If your company has interest in biocidal products containing QUATS (including specific ones as well as combinations of QUATs), this consortium is for you. Together, CEHTRA and Steptoe & Johnson LLP offer a unique combination of in-depth expertise and understanding of the regulatory and legal requirements to provide seamless support and maximise value for all consortium members. Besides cost reduction, this umbrella consortium will will provide answer to all your interests for QUATs. Interested to know more? Attend one of our upcoming QuAC webinars where the team will present key aspects of this consortium – QuAC concept, strategy and costs. To register your interest, please get in touch with CEHTRA experts Nathalie Hanon, Cyril Durou and Annekathrin Faupel and Eléonore Mullier from Steptoe & Johnson LLP. Introducing 1bCoF consortium Posted on: 8 / 6 / 2020 1bCoF (stands for 1 biocides Co-Formulant) – first reliable Co-Formulants tool that belongs to Biocides community. 1bCoF is the first consortium with a digital touch where Biocides experts and companies can reliably and securely contribute, share and access valuable information on co-formulants. Check out more details on 1bCoF consortium on our Biocides page. If you are interested to join one of our interactive webinars on 1bCoF, please contact our Biocides experts Nathalie HANON, Cyril DUROU and Annekathrin FAUPEL to be added to the list of webinar attendees. CEHTRA Training: Sécurité des produits cosmétiques Posted on: 7 / 6 / 2020 CEHTRA propose une journée de formation consacrée à la sécurité des produits cosmétiques, le 17 septembre 2020, à distance. La formation rappellera les obligations règlementaires pour les produits cosmétiques et abordera celles qui sont spécifiques aux matières premières. Elle traitera de tous les sujets utiles à une bonne gestion de la sécurité du produit : données documentaires, tests in vitro et cliniques, profils toxicologiques, calculs de MOS, impuretés, CMR, perturbateurs endocriniens, cosmétovigilance… Des exemples pratiques illustreront toutes les notions théoriques. CEHTRA attends SETAC SciCon meeting 2020 7 / 6 / 2020 Posted on: Cyril Durou from CEHTRA will be presenting a poster today at the SETAC SciCon meeting on Co-formulants of biocidal products under the biocide regulation: challenges and perspectives. If you are attending this conference, do not hesitate to take a look at our poster. Cyril Durou will be happy to answer your questions. ​ CEHTRA is also one of the exhibitors at this meeting, so if you have any questions for us, our booth representatives Cyril Durou, Estelle Beltran and Pauline REMUZAT will be happy to help. CEHTRA gets a new logo and motto Posted on: 6 / 6 / 2020 For many of us, these past weeks were about adaptation, change and hope. As we are stepping into the world after, CEHTRA team thanks you for your continued trust. Your specialty products are unique on their markets. Our expertise is our mark of recognition. Hand in hand, Your Specialties and Our Expertise, can contribute to a better and a safer tomorrow. And guess what, this is also our new motto! Your Specialties, Our Expertise That comes with a new logo to emphasize our enhanced value proposition! Chemical Watch Biocides Symposium Posted on: 31 / 5 / 2020 Are you attending the Chemical Watch Biocides Symposium this week? Eléonore Mullier from Steptoe & Johnson LLP, Nathalie Hanon from CEHTRA and Gerard McElwee from Fieldfisher will be presenting a talk on Industry Covid-19 mobilisation: Disinfectant Practical Guide on 28th May at 13:45 CEST. CEHTRA is contributing to the on-going efforts in fighting COVID-19. 29 / 5 / 2020 Posted on: CEHTRA is contributing to the on-going efforts in fighting COVID-19. To help ensuring a rapid availability of disinfectants across the EU during COVID-19 pandemic, a Practical Guide on Fast-Tracking the Supply of Disinfectants has recently been published with the initiative of AISE International Association for Soaps, Detergents and Maintenance Products, EBPF (the European Biocidal Products Forum) and FECC (the European Association of Chemical Distributors) with voluntary contributions from Fieldfisher Belgium, Steptoe & Johnson LLP and CEHTRA. The version 1.2 of this guide was made available on the 27th April. Got questions? Our Biocides expert Nathalie Hanon will be happy to provide more details. News 11 Posted on: Date 11 Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. News 12 Posted on: Date 12 Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. News 13 Date 13 Posted on: Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. 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  • 1bCoF | CEHTRA

    Imagine w n he Co-formulants’ knowledge is powered with digital technology Introducing reliable First Co-formulants tool that belongs to Biocides community What is 1b CoF ? It’s a concept , a tool and a vision designed for Biocides community by its experts. 1bCoF is the first consortium with a digital touch where Biocides experts and companies can reliably and securely contribute, share and access valuable information on co-formulants. With it’s easy to use interface, information remains at your fingertips and accessible anywhere, anytime. Why 1b CoF ? It provides across the biocides industry to minimize the regulatory risk of new products, optimize their time-to-market and . one reliable source of harmonized data shield their brands ​ It saves by allowing a shared access to existing co-formulants data. costs, time and resources ​ It with for all your R&D and Regulatory needs. shares costs to compile data one reliable and harmonized platform for co-formulants ​ It brings additional support from biocides experts to help you with at . regulatory compliance optimized costs Downloads 1bCoF advert Key Contacts Nathalie HANON General Manager & industry expert nathalie.hanon@cehtra.com Cyril DUROU Technical Manager & Deputy General Manager cyril.durou@cehtra.com Annekathrin FAUPEL Germany Coordinator & Deputy Technical Manager annekathrin.faupel@cehtra.com Nathanaëlle DANGLADES Data Manager nathanaelle.danglades @cehtra.com Latest Announcements The schedule for next webinars will be available soon. 1b CoF Please visit this page regularly for all future updates.

  • Our Expertise | CEHTRA

    Our Expertise Biocides Are you required to renew an approval of an active substance, to submit a product authorization or BPF dossier, to apply for Article 95 List inclusion or for Technical Equivalence? Chemicals (REACH) A solid, highly experienced team focussed on helping you meet your compliance deadline. ​ Cosmetics Demonstrate the safety of both your finished products and ingredients. Get the packaging safety tested. Shorten the time to market ​ Global Chemicals Notification Our internal tools designed to provide you the best worldwide, personalized and optimized strategy for a minimum cost. ​ Industrial Hygiene CEHTRA's industrial hygienists have decades of experience working with clients in their industrial sites and manage Environmental, Health and Safety challenges with a well balanced mix of technical expertise and practical experience. ​ Packaging Experienced, quality support in managing complex and constantly evolving regulation on packaging. ​ Pharmaceuticals For the safety of your pharmaceutical substances & products we can assist you in the development of your new drugs, safety of your drug production and generation of environmental risk assessment. ​ Plant Protection As a manufacturer or a distributor in the field of agriculture, you want to get your substances approved efficiently and get your Plant Protection Products on the market. ​ REACH Authorisation REACH Authorisation is an European risk management measure which aims to limit human and environmental exposure to substances considered of very high concern. Our Expertise Biocides Are you required to renew an approval of an active substance, to submit a product authorization or BPF dossier, to apply for Article 95 List inclusion or for Technical Equivalence? Chemicals (REACH) A solid, highly experienced team focussed on helping you meet your compliance deadline. ​ Cosmetics Demonstrate the safety of both your finished products and ingredients. Get the packaging safety tested. Shorten the time to market ​ Global Chemicals Notification Our internal tools designed to provide you the best worldwide, personalized and optimized strategy for a minimum cost. ​ Industrial Hygiene CEHTRA's industrial hygienists have decades of experience working with clients in their industrial sites and manage Environmental, Health and Safety challenges with a well balanced mix of technical expertise and practical experience. ​ Packaging Experienced, quality support in managing complex and constantly evolving regulation on packaging. ​ Pharmaceuticals For the safety of your pharmaceutical substances & products we can assist you in the development of your new drugs, safety of your drug production and generation of environmental risk assessment. ​ Plant Protection As a manufacturer or a distributor in the field of agriculture, you want to get your substances approved efficiently and get your Plant Protection Products on the market. ​ REACH Authorisation REACH Authorisation is an European risk management measure which aims to limit human and environmental exposure to substances considered of very high concern.

  • Careers | CEHTRA

    Job openings Introduction in 3 lines. Introduction in 3 lines. Introduction in 3 lines. Introduction in 3 lines. Introduction in 3 lines. Introduction in 3 lines. Introduction in 3 lines. ​ Internships Introduction in 3 lines. Introduction in 3 lines. Introduction in 3 lines. Introduction in 3 lines. Introduction in 3 lines. Introduction in 3 lines. Introduction in 3 lines. ​

  • Job Openings | CEHTRA

    Job openings CEHTRA is always looking to recruit new team members that can add strength and depth to our existing staff and contribute to the growth of the company. Would you like to join this friendly yet consciencious and professional group? CEHTRA recruits its consultants on the basis of their broad experience, scientific curiosity, and enthusiasm to take on a challenge. If you are interested, drop us your details via the 'contact us' form. ​ If you think that you have the right attributes, such as scientific competence, innovative mind-set and strong work ethic then send us a copy of your CV: recruitment@cehtra.com ​ Job title 1 Posted on: Job 1 date Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat Click here for more details Job Title 2 Posted on: Job 2 date Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea Click here for more details Job title 3 Posted on: Job 3 date Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Click here for more details Job title 4 Posted on: Job 4 date Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Click here for more details Job title 5 Posted on: Job 5 date Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Click here for more details Job title 6 Posted on: Job 6 date Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Click here for more details Job title 7 Posted on: Job 7 date Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Click here for more details

  • Internships | CEHTRA

    Internships CEHTRA is always looking to recruit new interns that can add strength and depth to our existing staff and contribute to the growth of the company. Would you like to join this friendly yet consciencious and professional group? ​ If you think that you have the right attributes, such as scientific competence, innovative mind-set and strong work ethic then send us a copy of your CV: recruitment@cehtra.com Stage 6 mois Ecotoxicologie et Toxicologie Reglementaire Posted on: 5 / 6 / 2020 Dans le cadre de ce stage, le/la candidat(e) s’intéressera : i) aux approches décrites dans les documents guides pour l’évaluation de risque pour l’Homme et l’Environnement de produits biocides présentant plusieurs substances d’intérêt ii) à la mise en place d’une procédure pour l’évaluation de risque combiné, comprenant notamment : a) le développement d’une méthodologie pour la récupération ou production de données de physico-chimie, d’écotoxicologie, de toxicologie, de comportement dans l’environnement des substances d’intérêt, nécessaires à l’évaluation de risque b) l’automatisation et la priorisation des approches de caractérisation du danger et d’évaluation du risque d’un mélange pour l’Homme et pour l’Environnement c) le développement d’une méthodologie pour le « screening » des effets de synergie entre substances d’intérêt d) Ce stage s’inscrit dans une démarche globale d’harmonisation dans la réalisation des dossiers de demande d’autorisation. A ce titre, l’étudiant(e) sera amené(e) à échanger avec les collaborateurs en charge de la classification des produits (règlement CLP), de l’identification des SoCs et perturbateurs endocriniens, et de l’évaluation de l’exposition humaine et environnementale aux produits. Click here for more details Job Title 2 Posted on: Job 2 date Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea Click here for more details Job title 3 Posted on: Job 3 date Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Click here for more details Job title 4 Posted on: Job 4 date Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Click here for more details Job title 5 Posted on: Job 5 date Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Click here for more details Job title 6 Posted on: Job 6 date Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Click here for more details Job title 7 Posted on: Job 7 date Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Click here for more details

  • REACH Authorisation | CEHTRA

    REACH Authorisation REACH Authorisation is a European risk management measure which aims to limit human and environmental exposure to substances considered of very high concern. All the users in terms of REACH definition (formulators, importers, downstream users) of one of the Annex XIV substances in Europe must carry out an Authorisation dossier to continue to be able to use the substance in question. CEHTRA's team is experienced and the entire dossier is done in-house, from the exposure estimation to the assessment of socio-economic impacts. Meet our expert Stephane PIERRE Head of REACH Authorisation stephane.pierre@cehtra.com Key Services Complete Authorisation dossier Advocacy Conformity Prioritisation/ Anticipation Drafting the whole dossier in coherence (CSR, AoA, SEA) Protect your interest (regulatory watch, supply chain securisation, public consultation...) Toward the Authorisation or restriction obligation Anticipate the regulatory obligation based on the hazard for your substance portfolio Value-added Services All the dossier parts are performed internally Several dossier submitted with success Member of the NerSAP(Network of REACH SEA and Analysis of Alternatives practitioners) Tox / Ecotox hazard assessment based on SVHC properties Regulatory scoring based on the supporting information Draft the Analysis of Alternatives based on client’s data Downloads REACH Authorisation Flyer - EN Key Contact Stephane PIERRE Head of REACH Authorisation stephane.pierre@cehtra.com Related Sectors Chemicals (REACH)

  • Locations | CEHTRA

    Our DNA is international ​ Click on the country below for more details North America Canada Europe Belgium Asia India France Germany Luxembourg Spain United Kingdom . . . Address1 City1 Tel1 Address2 City2 Tel2 Address3 City3 Tel3

  • Company Profile | CEHTRA

    Company Profile CEHTRA is an international leader in technical and regulatory support with regard to the safety of chemical products. Our focus is on scientific and innovative solutions ensuring regulatory compliance of chemicals to international obligations: from portfolio strategy to notification of chemicals and from human exposure to site audits. CEHTRA consultants provide high quality regulatory services to companies such as yours committed to the safety of their products at optimized costs. ​ CEHTRA differentiates itself by responding to the strategic challenges of its clients by: ​ A wide range of services including outsourcing (known as "Regie" in France), industrial hygiene and consortia management on one hand, and tools for digital disruption to save time and costs on the other. ​ Alternative regulatory strategies to accelerate the time to market of products thanks to industrial and international expertise recognized for almost 20 years. ​ An innovative blend of proven scientific and digital solutions: endocrine disruption, QSAR and Read-Across support, Data and Management tools such as CEHTRAPEDIA, PRIMO etc. ​ Our Vision ​ Today's safe chemicals are a key to tomorrow's sustainable future. ​ Combining our scientific expertise and years of consulting experience, we remain committed to our clients to ensure safety of their chemicals, thus contributing to the global efforts to protect biodiversity for a safer future. ​ The three key aspects defining CEHTRA's vision are: Client Backing Scientific Expertise Biodiversity Protection

  • Global Chemicals Notification | CEHTRA

    Global Chemicals Notification When it comes to chemical regulatory compliance, there is no ‘one method fits all’ approach. Here at CEHTRA we have developed our own internal tools designed to provide you the best worldwide, customized, and optimized strategy for a minimum cost. Our expert practitioners have collectively decades of experience and using our PRIMO tool are able to identify the most up to date regulatory requirements for the designated target countries. We prepare the Master dossier on which all other submissions are based. When required, our partners, chosen for their geographic proximity, language, and culture have the skills to prepare your local submission dossiers. Meet our experts Aurelie SEVESTRE-HERBELET Head of Global Notifications aurelie.sevestre@cehtra.com Damien GUYOMAR Toxicologist damien.guyomar@cehtra.com Melanie HARPER Regulatory Affairs Specialist melanie.harper@cehtra.com Key Services Global Registration Strategies Registration schemes adapted to your needs Scientific Expertise Data Gap analysis, Testing strategy (incl. alternatives to in vivo testing), Scientific support Testing Programme Monitor testing adapted to local requirements Registration Dossiers Preparation of Country-compliant dossiers & communication with authorities Value-added Services PRIMO tool to optimize management and follow-up of complex worldwide registration projects Scientific and Regulatory expert advices Only Representative services Countries covered EU countries United Kingdom Russia Turkey Switzerland USA Canada China Australia Thailand South Korea Japan Philippines Taiwan Others on application Downloads Global Chemicals Notification Flyer - EN Tools Related Sectors Chemicals (REACH) Industrial Hygiene REACH Authorisation

  • Chemicals (REACH) | CEHTRA

    Chemicals (REACH) A solid, highly experienced team focused on helping you meet your compliance deadline. You're in safe hands. A solid REACH dossier will enable you to put your substance on the market serenely. Your product is your priority, you are ours. During REACH Phase 1, 2 & 3 CEHTRA provided high quality technical and regulatory support and obtained extensive experience which can be a real asset to industry faced with the challenge of managing, completing and updating dossiers. ​ Moreover, by implementing Regulation (EU) 2020/1435 of 9 October 2020, the European Commission has now clarified when companies need to update their REACH registration dossiers. to read more about how CEHTRA experts can assist you with REACH registration dossier updates. Click here Meet our experts Mathieu ROLLAND Head of REACH mathieu.rolland@cehtra.com Aurelie SEVESTRE-HERBELET Senior Toxicologist aurelie.sevestre@cehtra.com Brigitte CASENAVE Senior Chemist brigitte.casenave@cehtra.com Key Services Dossier compilation & update Lead registrant and co-registrant dossiers testing strategy SIEF Management Consortium and SIEF communication, administrative and financial management of LoA Only Representative Representation of non-EU companies through our Only-Representative (OR) Legal Entity and UK-REACH Supply-chain management Obligations as EU importer, manufacturer or Downstream-User (DU), notifications to ECHA CEHTRA's consultants have been involved in the preparation of hundreds of REACH registration dossiers, acting on behalf of either the Lead Registrant or a coregistrant. ​ Industrials have successfully experienced CEHTRA and they continue for reviewing their product portfolio and strategy for REACH registration of substances, adapting testing strategies, expert regulatory and scientific advices. REACH dossier registration updates Implementing Regulation (EU) 2020/1435 of 9 October 2020, the European Commission has now clarified when companies need to update their REACH registration dossiers. ​ The requirement to update ‘without undue delay’ is in most cases specified as three months and, in more complex cases, up to 12 months. ​ Additionally, Cefic, through its multi-annual Action Plan, provides a framework for REACH registrants to evaluate the safety data in a stepwise manner. IUCLID Migration Dossier Review Lead Registration dossier update Co-registration dossier update Full update for IUCLID 5 dossiers and TCC passing for dossiers submitted in older versions of IUCLID 6 ​ Listing vulnerabilities and corrective actions and expert advice to tackle them a) Boundary composition including all SIEF information b) Outcomes associated to new studies c) CSR with CHESAR a) New UVCB qualities b) New impurity profile c) Impact for C&L d) Tonnage update We have indeed a large amount of experience in the update process: i) IUCLID Migration Services ​ Only by using the Technical Completeness Check (TCC) tool in the latest version of IUCLID (6.5.1.2) can you ensure your submission will pass the first submission processing steps in REACH IT. ​ IUCLID 5.6 and newer files can be imported directly into the latest version of IUCLID (6.5.1.2) however they will most likely fail the latest Technical Completeness Check (TCC) and therefore need updating. Any IUCLID files older that 5.6 will not import into the latest IUCLID directly and would need to be updated in a stepwise process. ​ If you need to make submissions to the UK competent authority after Brexit you will also need to pass the latest TCC check. ​ Our team has good experience with IUCLID migration services. If you have any questions, write to one of our experts or simply drop your query in the chat window below and one of our experts will get back to you. ii) Joint Submission Services ​ CEHTRA experts accompany: a) Companies to update their dossier within or without the CEFIC Action Plan ​ b) Lead Registrants for preparing the dossier updates and associated costs taking other SIEF members into consideration. ​ c) Co-registrants when supply-chain and/or composition has been modified. Value-added services Cost-sharing and data-sharing UVCB registration Alternative testing strategies Expert advice Study monitoring PRIMO tool to optimize management and follow-up of data Downloads REACH Flyer - EN Key Contacts Mathieu ROLLAND Head of REACH mathieu.rolland@cehtra.com Aurelie SEVESTRE-HERBELET Senior Toxicologist aurelie.sevestre@cehtra.com Brigitte CASANAVE Senior Phyiso-Chemist brigitte.casanave@cehtra.com Related Sectors Global Notifications Industrial Hygiene REACH Authorisation

  • Representative services | CEHTRA

    Representative Services Representation allows companies to place a substance on a market in an area where they may not have a legal presence. This has a number of benefits including the protection of confidential information and the ability to supply to numerous customers within a particular country/economic area under one registration. In the EU this role is known as Only Representation (OR) and allows a non-EU manufacturer to appoint an Only Representative to fulfill EU regulatory obligations on their behalf. This form (or similar forms) of representation is also available in a number of other countries. CEHTRA has sites in both the EU and UK and is able to offer Only Representative services under REACH as well as Article 95 Representation under both the EU and UK BPR. With the assistance of locally based partners, we are also in a position to offer representative services in Korea, Russia and Turkey. Meet our experts Melanie Harper Regulatory Affairs Specialist melanie.harper@cehtra.com Karl Willoughby Regulatory Affairs Specialist karl.willoughby@cehtra.com Key Services EU REACH OR/ Article 95 Representation UK REACH OR/ Article 95 Representation K-REACH OR (Korea) KKDIK OR (Turkey) CEHTRA can act as "only-representative" and consultant for non-European Union companies who sell, or intend to sell, in the European Union (+ European Economic Area (EEA) countries) substances, preparations (mixtures), or articles which are submitted to REACH regulations. ​ CEHTRA offers an expert service, carried out by personnel with extensive experience in both Only Representative Services and REACH Registration. CEHTRA can act as the EU Representative for a non-EU manufacturer for the purpose of Article 95 listing of the BPR. ​ CEHTRA offers an expert service, carried out by personnel with extensive experience in the area of Biocidal regulation. CEHTRA can also provide advice and assistance with Representative Services required under global regulatory schemes, including OR under UK REACH, should this be required as a result of Brexit. ​ With the assistance of locally based partners, we are able to provide Representative Services in Korea, Turkey, and Russia. Value-added Services Dossier/Substance management SDS preparation Point of Contact for customers Related Sectors Global Chemicals Notification Chemicals (REACH) Key Contacts Melanie Harper Regulatory Affairs Specialist melanie.harper@cehtra.com Karl Willoughby Regulatory Affairs Specialist karl.willoughby@cehtra.com

  • Biocides | CEHTRA

    Biocides Are you required to renew an approval of an active substance, to submit a product authorization or BPF dossier, to apply for Article 95 List inclusion or for Technical Equivalance? Our broad experience in supporting active substances and biocidal products is your best guarantee. Among the multiple uses covered by Biocidal Product Regulation (EU) 528/2012 (BPR), which one is yours: Disinfectants? Wood preservatives? Rodenticides? Insecticides? ​ Entrust your dossier into experienced hands! ​ Meet our experts Nathalie HANON Head of Biocides nathalie.hanon@cehtra.com Cyril DUROU Senior Ecotoxicologist cyril.durou@cehtra.com Annekathrin FAUPEL Senior Regulatory Manager annekathrin.faupel@cehtra.com Key Services Product Authorization Biocides Product Family Single Product EU R&D Notifications Active Substance Active Substances Annex I inclusion Article 95 Listing Dossier Preparation Testing strategy Study Monitoring Alternatives to animal testing Consortium Management Biocide Product Family Consortium containing specific active substances CEHTRA's consultants has been involved in the preparation of several active substances Annex I inclusion dossiers and submission of biocidal products through the BPR process and under National schemes. ​ Our team has also successfully completed many Biocide Product Registration and Biocide Products Family dossiers from start to finish without counting the numerous projects for regulatory support, Monitoring, Outdoor Operator Exposure Studies, Expert Advice and Position Papers. Value-added Services Assessment of ED properties Negotiations with Authorities Worldwide Compliance Risk Assessment and Modelling Technical Equivalance Data Sharing Negotiations Downloads Biocides Flyer - EN Tools Related Sectors Plant Protection