Are you prepared for a Pre-Approval Inspection?
A successful PAI is an essential part of bringing your drug to market. This white paper offers an FDA perspective on pre-PAI readiness based on more than 15 years of FDA pharmaceutical investigator and CBER reviewer knowledge.
In this white paper, you will learn:
- History of the pre-approval inspection process
- An overview of the process
- How to know if your company is ready for a PAI