- Impurity Qualification as per Regulatory Guidelines (EMA/FDA/ICH)
- Permitted Daily Exposure (PDE) & Occupational Exposure Limit (OEL) derivation for active pharmaceutical ingredients (API)
- Toxicological Hazard Assessment of Pharmaceutical Excipients
- Environmental Risk Assessment (ERA) of active pharmaceutical ingredients (API)
- Non-clinical Studies Literature Search & Data Compilation
- Extractable & Leachable Toxicological Risk Assessment
Sagarvati Scientific & Regulatory Consulting LLP
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