We quickly assess your quality system, its implementation, and recent challenges. We provide a prioritized risk assessment to address critical gaps and ensure your team understands FDA requirements and expectations.

We simulate FDA inspections, often using ex-FDA investigators, to help your team practice under realistic pressure. Post-mock training includes constructive feedback and real-life scenarios to improve readiness and response to FDA practices.

We train your team on document management, emphasizing organization, accessibility, and clarity to meet FDA expectations. We also assist with critical reviews and “story” preparation, ensuring you're ready for challenging CAPA discussions.

We coach your team to communicate effectively during FDA inspections, ensuring responses are concise, accurate, and professional, fostering trust and demonstrating compliance.

Our experts prepare you to handle FDA investigators, providing guidance on managing open-ended or challenging questions to navigate inspections confidently and successfully.

We train your team on post-inspection responses, including addressing form 483 observations and preparing for follow-ups. Our guidance ensures effective corrective and preventive actions for lasting compliance.