Post by Solvias

If your Extractables & Leachables (E&L) strategy isn’t built early—and built right—it can quickly turn into a regulatory roadblock. Recent FDA Complete Response Letters (CRLs) highlight this risk, with nearly 1 in 5 citing E&L-related deficiencies. In this Q&A, Christopher Latendresse, Ph.D.,Director of Analytical Services, Solvias E&L Center of Excellence, shares what a submission-ready E&L package should include—and how teams can avoid preventable CRLs. 📥 Download it here: https://lnkd.in/exG6eYEZ #ExtractablesAndLeachables #CRLs #RegulatoryAffairs #CMC #DrugDevelopment #Pharma #Biotech