pre approval inspection

Clinical Research Solutions

How to Ensure Your Device, Software, and Drug Are All Ready for a Pre-Approval Inspection

When drug or device manufacturers apply for marketing approval of a new product, the FDA may conduct a pre-approval inspection (PAI). The PAI is performed to help the Agency assure that a...

Clinical Research Solutions

6 Tips for Evaluating Your CMO’s PAI Readiness

The submission of your drug application (NDA, ANDA, BLA, etc.) is an exciting accomplishment, and one of the first major milestones is a pre-approval inspection (PAI) of the manufacturing sites...

Clinical Research Solutions

Conducting a PAI Mock Inspection: How to Execute and Evaluate Your Findings

Did you miss our last blog on PAI Readiness? Catch up here to learn what a PAI is and how to prepare. Congratulations! You conducted a Mock Inspection in preparation for your upcoming Pre-Approval...

Inspector writing down notes at a clean facility.

Quality & Compliance

Pre-Approval Inspection (PAI): What it is and How to Prepare

What is a Pre-Approval Inspection (PAI)? A pre-approval inspection (PAI) is performed to provide the Food and Drug Administration (FDA) assurances that a manufacturing site named in a drug...