TOXICOLOGY & RISK ASSESSMENTS
Toxicology and risk assessment are essential in the pharmaceutical industry to ensure drug safety and efficacy. Through thorough analysis, toxicology assesses potential risks and adverse effects, while risk assessment evaluates their likelihood and severity. Trust our expertise for safe and compliant pharmaceutical endeavors.
Services We Offer
- De-risking of drug candidates in early discovery phases by custom-made tox-strategies
- Risk assessment and strategies for qualification of process impurities and other contaminants
- Toxicological information for drug labelling
- Non-clinical sections of INDs/NDAs/ANDAs/MAAs in legacy and eCTD format
- Due Diligence and Data Gap Analysis
- Derivation of occupational exposure limits (OEL/OEB) & permissible daily exposure (PDE)
- Environmental Risk Assessment (ERA) of pharmaceuticals
- Risk assessment for Extractables & Leachables (E&L)