Report – Strategic PAI Readiness: A Data-Driven Approach for Pharma Sponsors and Manufacturers

A data-driven look at how manufacturers and sponsors can prepare effectively for Pre-Approval Inspections (PAIs) / Pre-License Inspections (PLIs).

In the high-stakes world of pharmaceutical approvals, PAIs and PLIs represent a critical hurdle. Unlike routine GMP inspections, they focus intensely on a facility’s readiness to manufacture a specific product at commercial scale.

This report analyzes FDA human drug and biologics inspection data from 2020 through 2025 to identify how PAI and PLI focus areas, inspection outcomes, and enforcement trends differ from those of routine GMP inspections. It outlines key risk indicators and a staged approach to inspection readiness that helps sponsors and manufacturers reduce risk across sites and supply chain partners. This report also includes an industry perspective from Diana Aberion, Senior Director of Audits and Inspection Management at Gilead Sciences.

Download your copy of the report to understand PAI risk drivers, benchmark inspection trends, and apply a practical, staged framework for inspection readiness across your organization and partners.