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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 (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

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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