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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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Soline DION

Deputy Market Leader

 soline.dion@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