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Produits Pharmaceutiques

PHARMACEUTICALS
(Human & Veterinary)

For the safety and efficacy of both human & veterinary pharmaceuticals, CEHTRA can assist you in:

  • The definition of your preclinical development (development plan) and the drafting of your regulatory dossiers (nonclinical modules)

  • The safety of your CMC activities (PDE, OEL/OEB, qualification of impurities)

  • The Environmental Risk Assessment (ERA) for your MAA dossier

Description

Meet our experts

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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

Key Services

CMC Support

Nonclinical sections of Regulatory Dossiers

Preclinical Development

Environmental

Risk Assessment

   Production Safety

  • PDE Calculation

  • Qualification of Impurities

  • Toxicological Evaluation of Extractables & Leachables

   Workers' Safety

  • OEL/OEB Calculation

  • Authoring CTD, CTA, IND, IMPD, IB, Briefing documents

  • CTD updating

  • Critical review of modules

  • Preclinical Development Plans

  • Study Monitoring

  • Clinical Trial Autorisation: Authoring CTA, IND, IMPD

  • Expertise in Pharmacology, Pharmacokinetics & Toxicology

  • Study Monitoring

  • Authoring the ERA - Phases I & II

  • Interactions with Competent Authorities (EMA, FDA)

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 Toxicologist & Deputy Head of Pharmaceuticals

alexandra.bonnefont@cehtra.com

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

Added Value

Recognized Toxicologists & Ecotoxicologists: Pharmacists, ERT Toxicologists and Engineers with > 20 years of experience

A toxicological expertise supported by in silico methods: QSAR models with Nexus, DEREK and Leadscope + 1 dedicated QSAR Expert

A demonstrated expertise within the pharmaceutical field: We gained the trust of major groups and small companies

Independence from CROs

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