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Produits Pharmaceutiques

PHARMAZEUTIKA

(Human- & Tiermedizin)

Um die Sicherheit Ihrer pharmazeutischen und veterinärmedizinischen Wirkstoffe und Produkte zu gewährleisten, bietet CEHTRA folgende Dienstleistungen an:

  • Sicherheit Ihrer Arzneimittelwirkstoffe und Arzneimittelprodukte: Entwicklung, Erstellung & Einreichung von  Zulassungsanträgen

  • Sicherheit Ihrer Arzneimittelproduktion (PDE, OEL/OEB, Bewertung von Verunreinigungen)

  • Erstellung von Umweltrisikobewertungen für Ihr MAA-Dossier

Description

Ihre Ansprechpartner

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Stephane PIERRE, PharmD, PhD, ERT

Head of Pharmaceuticals, Senior Toxicologist Expert

stephane.pierre@cehtra.com

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Blandine JOURNEL, PhD, ERT

Senior Ecotoxicologist Expert

blandine.journel@cehtra.com

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Alexandra BONNEFONT, Engineer

Deputy Head of Pharmaceuticals, Nonclinical Expert

alexandra.bonnefont@cehtra.com

Contact

Unsere Leistungen

PDE und OEL/OEB Berechnungen

Sicherheitsbewertungen von Verunreinigungen

Vorklinische Gutachten

Umweltrisikobewertungen

Sicherheitsbewertung der Arzneimittelproduktion und der Arbeitnehmer vor Ort (PDE, OEL/OEB)

Sicherheitsbewertung von Verunreinigungen in Arzneimittelwirkstoffen

oder Produkten

(ICH- und VICH-Richtlinien)

Entwicklungspläne, Studienüberwachung, Erstellung von Zulassungsdossiers

(CTA, MAA...)

Abdeckung der gesamten Umweltrisikobewertung des Antrages zur Marktzulassung (Dossiererstellung, Studienüberwachung, Verteidigung bei Behörden...)

Key Services

To ensure the safety and efficacy of both human & veterinary pharmaceuticals, CEHTRA experts support you in your:

  • CMC activities: PDE (Permitted Daily Exposure) Calculation, OEL/OEB (Occupational Exposure Limit / Occupational Exposure Band) Calculations, Qualification of impurities, Toxicological evaluation of extractables-leachables, In silico assessment (QSAR)

  • Preclinical development plan: Development plan design, Study monitoring (CROs selection, Validation of protocols & study plans, Study follow-up, Discussion of the results, Review of final study reports), Clinical Trial Applications, Gap analysis

  • Regulatory dossiers: Authoring nonclinical sections of CTD, CTA, IND, IMPD, Investigator Brochure (IB), Briefing Documents ; Updating & making a Critical Review of nonclinical modules (2.4 & 2.6, module 4) ; Regulatory Toxicology.

  • Environmental risk assessment: Study monitoring, ERA Drafting (Environmental Risk Assessment, Phase I & Phase II, Module 1.6) & Interactions with competent authorities (EMA, FDA) – Defense of the dossier.

CEHTRA expertise allows you to ensure the:

      Production safety by minimizing the risk of cross-contaminations (residual active substances from API) and impurities (residual solvents, elemental impurities, impurities with mutagenic potential, extractables & leachables,…)

      Workers’ safety by calculating occupational exposure limits

      Patient’s safety by designing adequate development plans and performing robust toxicological evaluations based on in silico, in vitro and in vivo data

With two main objectives:

  • Safely launch the production of your pharmaceutical product

  • Obtain the Clinical Trial Autorisation and the Marketing Autorisation (MAA)

 

In compliance with:

      ICH guidelines: ICH Q3A, Q3B, Q3C, ICH M7, VICH GL18, ICH M3(R2), ICH S1A, ICH S1B, ICH S5(R3),…

      EMA guidelines: Guideline on HBELs 2014, Guideline on control of impurities of pharmacopoeial substances, Guideline on the environmental risk assessment of medicinal products for human use…

Thanks to a recognized expert team (pharmacists, ERT toxicologists, engineers…)

Meet our Experts in charge of the Régie/Dedicated Support

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At CEHTRA, we put our experts at your disposal through our Dedicated Support in pharmaceutical sciences called "Régie"

Experts supported in-house by a team of senior toxicologists

A significant experience with the Dedicated Support:

  • >30 successful « Régies »

  • >10 years of experience with « Régies »

  • >10 on-going « Régies »

Maximum flexibility

Contracts

  • Short-term & Long-term

  • Extendables & Renewables

  • Part-time & Full-time

Modes

  • Embedded Staff: Our consultants work from our clients’ site

  • Extended Staff: Our consultants work from our offices but exclusively for our client

Flexible tariff depending on the expert profile selected (Junior, Specialist, Senior, Expert)

For more information, please visit our "Régie" dedicated web page

Need information or quotation? Do not hesitate to contact us:

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Dr Stéphane Pierre, PharmD, PhD, ERT & Head of Pharmaceuticals

stephane.pierre@cehtra.com

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Alexandra Bonnefont, Nonclinical Engineer & Deputy Head of Pharmaceuticals

alexandra.bonnefont@cehtra.com

Meet our Experts in charge of the Régie/Dedicated Support
Value-added

Leistungen und Qualifikationen

Kompetentes Team von Toxikologen und Ökotoxikologen (sowie QSAR-Experten)

QSAR-Unterstützung mit Nexus DEREK und Leadscope

Dossier-Verteidigung

Daten- und Literaturanalysen

Trainings
Emballages | Formations

Trainingskurse

19 March. 2024

Regulations in Europe and the USA for recycled plastics
intended for contact with food and in cosmetics

Media

Videos

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