Inside, You’ll Learn:
How to prepare for facility inspections and close legacy 483s
What the FDA expects for container closure and stability evidence
How to prove process robustness and portability across sites
We Analyzed the 2025 CRLs - So You Can Act
Where Issues Concentrate; Six Practices that Work; A Reviewer’s Checklist
Download our latest whitepaper, “A New Blueprint for CMC Success: Analyzing the FDA’s 2025 CRL Release", analyzing the FDA’s unprecedented 2025 release of more than 200 Complete Response Letters (CRLs).
For the first time, sponsors can move beyond second-hand accounts and conjecture, drawing instead on a structured dataset that reveals where CMC programs most often encounter problems.
Why analytical methods and impurity controls are under new scrutiny
The role of digital backbones in modern CMC programs