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
Key Services
PDE and OEL/OEB Calculations
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Safety assessment of drug production and workers on site (PDE, OEL/OEB)
Safety Qualification of Impurities
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Safety qualification of impurities in drug substances or products (ICH and VICH guidelines)
Preclinical
Expertise
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Development plan, study monitoring, writing regulatory dossiers (CTA, MAA...)
Environmental
Risk Assessment
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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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