The Pre-Approval Inspection (PAI) can be a “make-or-break” moment during the CMC section review process of the New Drug Application (NDA). To prepare, many small and mid-size biopharma organizations will reach out to service providers to perform mock inspections. While those exercises are valuable, the seeds of a successful PAI are planted years before the FDA arrives at a manufacturing facility. Therefore, it is critical that sponsors take on a broader view of the CMC section.

Download this white paper for the key considerations you need to plan and position your organization for CMC success, including insights on:

1. Preparing for Process Justification and Validation

2. Executing Process Validation and Compiling the New Drug Application (NDA)

3. Filing the NDA and Completing the Pre-Approval Inspection