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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

Meet our experts

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Stephane PIERRE

Head of Pharmaceuticals

stephane.pierre@cehtra.com

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Maryse CORROLLER

Expert Toxicologist

maryse.corroller@cehtra.com

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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

  • Entire ERA part of the MAA is covered (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

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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