Pharmaceuticals (Human & Veterinary)
For the safety of your pharmaceutical and veterinary substances & products CEHTRA can assist you with:
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Safety of your drug substances and drug products: development and regulatory submissions.
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Safety of your drug production (PDE, OEL/OEB, impurities qualification)
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Generation of Environmental Risk Assessment (ERA) for your MAA dossier (Directive 2004/27/EC)
Meet our experts
Stephane PIERRE
Head of Pharmaceuticals
Maryse CORROLLER
Expert Toxicologist
Blandine JOURNEL
Senior Ecotoxicologist, ERA
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
Key Contacts
Stephane PIERRE
Head of Pharmaceuticals
Maryse CORROLLER
Expert Toxicologist
Blandine JOURNEL
Senior Ecotoxicologist, ERA
