Strategic Advice: FDA, CDMOs/CMOs and ATMPs
Day 2 Next-Gen Bio Stage
07/10/2026 15:15 - 15:40pm
Contributors
Donald D. Ashley : Principal, Regulatory Compliance - ELIQUENT Life Sciences
Whitney Sandberg : Partner, Quality and Compliance Practice - ELIQUENT Life Sciences
Have you properly managed your risk? The complexity of navigating the CMC, regulatory and quality compliance roadmap is a key strategic element for CDMOs in the ATMP (advanced therapy medicinal products) space. Plans typically include managing pain points such as sterility assurance, tech transfer, manufacturing at scale, quality control and managing costs.
US FDA’s unannounced inspections have increased dramatically. Many of these inspection outcomes have resulted in Complete Response Letters (CRLs) or Warning Letters – at least 96 of them have been to CDMOs and CMOs. This has a negative impact on your business, on your customers.
Regardless of market, the best course of action is to do everything you can to avoid a bad inspection. Executive commitment to quality is the key success factor. Building a robust quality culture leads to sustainable compliance, de-risking your business. ELIQUENT can help.