Industry Insights

  1. USP <665> Becomes Official On May 1, 2026. Are You Ready? 2/24/2026

    With USP <665> becoming official on May 1, 2026, proactive preparation is essential to ensure compliance and prevent delays, regulatory observations, or supply chain disruptions.

  2. 21% Of CGT Clinical Holds Stem From CMC Issues. What Does This Tell Us? 2/23/2026

    Cell and gene therapy (CGT) trials account for nearly 40% of all clinical holds reported by the NIH, with over 21% caused by CMC issues, often delaying approvals by over 6 months.

  3. What Defines Excellence In CMC Analytics? 2/21/2026

    In this podcast, our Chief Scientific Officer, Daniel Galbraith, shares candid insights into what separates operational vendors from true scientific collaborators. 

  4. Nearly 20% Of FDA CRLs Published In 2025 Cite E&L Deficiencies. How Can You Avoid Them? 2/20/2026

    If your Extractables & Leachables (E&L) strategy isn’t built early — and built right — it can quickly turn into a regulatory roadblock.

  5. What FDA CRLs Reveal About E&L 2/18/2026

    FDA feedback shows E&L gaps still delay approvals. This preview flags common issues — from unknown compounds to weak tox data — and offers ways to strengthen E&L approaches and cut regulatory risk.