QSAR (Quantitative Structure–Activity Relationship), genotoxicity evaluation, and nitrosamine risk assessment are essential components of regulatory compliance for APIs, intermediates, and finished pharmaceutical products. This function applies computational modelling, structural analysis, and toxicological expertise to identify, predict, and mitigate potential safety risks associated with impurities and degradation products. These assessments support robust control strategies, ensure alignment with global regulatory guidelines, and strengthen the overall CMC submission package.
Key Deliverables
- QSAR evaluations for actual and potential impurities, using validated computational tools
- Genotoxicity risk assessments, including classification, threshold of toxicological concern (TTC) determinations, and control strategy recommendations
- Nitrosamine risk assessments, including process mapping, root-cause analysis, and mitigation strategies
- Impurity assessment reports for inclusion in global regulatory submissions (IND/IMPD/NDA/DMF/ANDA)
- Documentation of structural alerts, toxicological justifications, and control limits for regulatory review
- Support for remediation activities, such as redesigning processes or establishing preventive controls to eliminate risk