|
|
|
|
Inside FDA CRLs: Learn What Went Wrong and How to Avoid It
Since the FDA began publishing Complete Response Letters (CRLs), we’ve been analyzing them to uncover where drug applications fall short—and how to avoid the same pitfalls. The result is a growing library of white papers translating real regulatory feedback into clear, actionable insights. Explore key lessons from E&L and CCIT, and discover our latest release focused on method validation. Download the full collection and strengthen your submission strategy:
|
|
|
|
|
In this webinar, Dr. Yannick Baschung explains when IVBE can credibly support a biowaiver — and when it can’t—and how to design robust, inspection‑ready IVBE strategies that withstand regulatory scrutiny and help speed approval.
|
|
|
|
|
USP <665> takes effect on May 1, 2026. Understanding extractables risk, material characterization, and how to align with regulatory expectations is key to avoiding delays. Make sure your strategy is on track — download our white paper.
|
|
|
|
|
When developing ADCs, a robust Drug-to-Antibody Ratio (DAR) strategy isn’t just nice to have. It's mission-critical. In our latest case study, we demonstrate how we supported a biopharma team in building an end-to-end DAR strategy that went far beyond reporting an average value.
|
|
|
|
|
If your Extractables & Leachables strategy isn’t solid, it can stall approval. Nearly 1 in 5 FDA Complete Response Letters cite E&L gaps. Christopher Latendresse, Ph.D., explains what a submission‑ready E&L package needs — and how to avoid CRLs.
|
|
|
|
|
|
|
As demand for advanced therapy testing grows, expanded GMP capabilities in Research Triangle Park support biologics, cell and gene therapies, and novel modalities from preclinical development through commercial release.
|
|
|
