“Big thanks to Thomas Regulatory Consulting Group for their impactful support in a critical moment. Facing a surge in product quality issues, their assessment identified potential triggers for a reactive FDA inspection and highlighted high risks areas where our Quality Management System needed improvement.
Post-engagement, we faced an FDA inspection confidently, thanks to their preparation. Khalil and his team’s expertise proved crucial in maintaining safety standards for our patients and users, and in protecting our business. Grateful for their invaluable partnership and positive impact on our Quality journey.”