Clinical And Non-Clinical Studies Services
- Nonclinical product development strategy for generic formulation and NCE.
- Toxicological risk assessment for impurities.
- Impurity qualification toxicology studies.
- Genotoxicity-mutagenicity- carcinogenicity ICHM7 assessments.
- PDE, OEL toxicology monographs for cleaning validation team support and occupational worker safety.
- Extractable and leachable toxicological assessment.
- In silico QSAR review and expert statements/interpretation
- Environmental/ecotoxicological risk assessment for EU (tier I only).
- Nitrosamines toxicological assessment - acceptable intake derivation.
- OOS safety assessments for known and unknown peaks in GMP batches.
- Human Food Safety assessments, drug residue in human food, ADI derivation for USFDA (CVM), EU (EFSA), Codex (JECFA), etc.
- Types of nonclinical studies Acute/repeated dose toxicity, genotoxicity - mutagenicity, clastogenicity, phototoxicity/allergy, kinetics-ADME/pharmacology efficacy studies, Impurity qualification toxicology studies, human food safety toxicity studies.