This function focuses on evaluating potential risks in drug substances and products and providing confirmatory testing to ensure analytical and process robustness. It supports regulatory compliance and safeguards patient safety by identifying critical quality attributes (CQAs) and assessing potential chemical, toxicological, or regulatory risks.
Key Deliverables
- Risk Assessment: Evaluating impurities, degradants, and process-related risks across APIs, intermediates, and formulations.
- Confirmatory Testing: Independent verification of critical analytical results, including potency, purity, stability, and impurity profiles.
- Impurity & Safety Profiling: Identification and quantification of potential genotoxic, mutagenic, or reactive impurities.
- Regulatory Compliance Support: Providing evidence and documentation to support IND, NDA, ANDA, and DMF filings.
- Process Monitoring & Quality Assurance: Ensuring that analytical and manufacturing processes meet quality standards and minimize risks.
- Data Integrity Checks: Verifying that generated data is accurate, reproducible, and traceable for regulatory inspections.