Receiving a Complete Response Letter (CRL) can feel like a major setback — but it’s also an opportunity to strengthen your submission and ultimately bring your product to patients. Our experienced team partners with you to turn regulatory challenges into a clear, achievable path forward.
Here’s how we help:
✅ Root Cause & Gap Analysis
We thoroughly review your CRL, submission files, and study or manufacturing data to identify exactly where the deficiencies lie and why they occurred. This sets the foundation for a targeted, effective remediation plan.✅ Regulatory Strategy &
✅ FDA Engagement
We develop a strategic roadmap to address each FDA concern. Our experts prepare you for Type A/B meetings, craft precise briefing packages, and support direct FDA interactions to ensure your response is aligned and persuasive.✅ CMC,
✅ Quality & Manufacturing Solutions
From process validation to stability studies to control strategy enhancements, we help design and implement robust technical fixes. We also prepare your facilities for re-inspection and support GMP remediation.✅ Submission Readiness &
✅ Documentation
Our team ensures all new data, analysis, and narratives are well-organized, scientifically justified, and fully responsive to FDA’s observations —minimizing back-and-forth and getting you to approval faster.✅ Project Leadership & Risk
✅ Management
CRL remediation often crosses clinical, regulatory, quality, and operations. We coordinate efforts across all functions, keep your program on track, and proactively manage risks to avoid future hurdles.✅ Long-Term Compliance & Team
✅ Strengthening
Beyond the immediate response, we train your teams on quality culture, data integrity, and regulatory expectations — reducing the risk of repeat finding sin future submissions.
QxP works to strengthen your knowledge through mentoring and coaching so you are prepared for the future and your actions are sustainable for the long-term.
QxP Vice President Christine Feaster is a 20+ year veteran in pharma quality assurance. Prior to joining QxP, Christine was a vice president of U.S. Pharmacopeia.
