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
Meet our experts
Soline DION
Deputy Market Leader
soline.dion@cehtra.com
Key Services
PDE and OEL/OEB Calculations
Safety Qualification of Impurities
Safety assessment of drug production and workers on site (PDE, OEL/OEB)
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
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