Dealing with an FDA Complete Response Letter (CRL) is one of the most stressful challenges in drug development, but managing one that stems from a failed inspection at your Contract Development and Manufacturing Organization (CDMO) adds a unique layer of business and operational complexity.

In this episode of Life Science Solutions, host Chris Adkins sits down with David Dlugo (Senior Director of Quality at Kymanox) and Anthony Stewart (Senior Process Engineer at Kymanox) to dissect a real-world case study of remediation and return to GMP manufacturing following a failed Pre-Approval Inspection (PAI).

The team explores how to navigate the delicate balance between a Sponsor’s need for oversight and a CDMO’s need to protect proprietary operations, often using a "middleman" strategy to diffuse tension and accelerate compliance.

Topics Include:

• The "Survival Mode" Dynamic: Understanding the friction between a Sponsor’s urgency and a CDMO’s competing resource demands.
• Common Technical Pitfalls: Why "basic GMPs" and process control strategies (like Annex 1/contamination control) are frequent stumbling blocks during first-time inspections.
• The Power of Generalists: Why deploying a team of deep, diverse experts is more effective than just "throwing bodies" at a remediation project.
• 6 Keys to Success: David shares six essential steps to prevent CRLs, including robust supplier qualification and monthly governance meetings.
• Ideal Knowledge Transfer: How to leave the CDMO better than you found it by mentoring staff and improving quality systems for the long haul.

Whether you are navigating a current regulatory hurdle or preparing for your first BLA, this conversation offers a strategic roadmap for turning regulatory complexity into clarity.