How to go from API to PAI: Together For Medicines that Matter
Before approving the commercial launch of an innovative small molecule drug in the US, the FDA will likely conduct a Pre-Approval Inspection (PAI) of the Active Pharmaceutical Ingredient (API) production facility. This inspection ensures the facility complies with current Good Manufacturing Practice regulations and verifies that the manufacturing process and analytical methods in the New Drug Application (NDA) are accurately documented, correctly executed, and capable of consistently producing the API to defined quality standards.
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Overview Of Contents
About PAI
- Key questions probed during PAI
Integrating Process Chemistry Early in Drug Development
- The importance of integration to reduce risks and delays
- Evotec’s API Platform
Scaling Up with Confidence: Ensuring API Quality and Efficiency
- Not just “if”, but rather “how” …
Elevating API Quality: Analytical Development’s Crucial Role
- A case study
The Solid State Matters
- A case study
Fueling Discovery: Evotec’s Cutting-Edge Toolbox and High Throughput Experimentation
Conclusions
