Just published! A new International Society of Pharmaceutical Engineering (ISPE) Guide: RNA-Based Therapeutics Manufacturing. Our President and Principal Consultant, James Blackwell, PhD, MBA/MS, was a…
Key Takeaways The FDA’s Advanced Manufacturing Technology (AMT) Designation Program, established under Section 506L of the FD&C Act, provides a framework for requesting designation of…
Background Thirteen years after the 2013 edition of PDA Technical Report No. 60 gave the industry its first comprehensive roadmap for implementing the lifecycle approach…
As a CMC and quality expert with over two decades in the biopharma industry, I've had countless conversations with leaders at small biotech companies and…
Executive Summary: The Bottom Line On January 11, 2026, the FDA moved from negotiated flexibility to a standardized flexibility framework for Cell and Gene Therapies (CGT). For our clients, this…
New FDA Draft Guidance on ICH Q3E: What Steps are Needed to Master the Risk-Based Framework for Extractables and Leachables Control? ICH Q3E represents a…
What Are the Best Practices for Bio/Pharma CMC Regulatory Compliance? A Proactive Guide to Documentation and Digital Strategy In the highly scrutinized bio/pharma industry, regulatory…
Introduction The U.S. Food and Drug Administration (FDA) is facing a significant shake-up with a recent workforce reduction of approximately 3,500 positions as part of…
In the biopharma industry, regulatory compliance and meticulous documentation are the bedrock of success. Especially as it relates to Chemistry Manufacturing and Controls (CMC). Small…
Introduction The U.S. pharmaceutical landscape is undergoing a transformative shift with the FDA’s “FDA PreCheck” proposal, launched under Executive Order 14293 to bolster domestic manufacturing…