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Are you prepared for a Pre-Approval Inspection? A successful PAI is an essential part of bringing your drug to market. Read this White Paper to get an FDA perspective on pre-PAI readiness based on over 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