Advisory committees and panel meetings are vital to the progression of your product and its success. These committees review NDAs, BLAs, and PMAs and advise FDA on the risk/benefit ratio of a new product. TRI guides and provides strategic support services for the preparation and throughout the entire process of for these meetings. For meeting materials, such as panel meeting packages, expert reports and sponsor presentations, TRI ensures all materials are completed on time to the highest quality. TRI identifies and provides subject matter experts for your specific therapeutic area. As contingency planning better enables your success at the FDA Advisory Meeting, we help prepare you by coordinating mock panels, preparing workshops, and providing practice sessions. Our services are the foundation for your product´s success.
- Advisory Committee and Panel Meeting Support
- Strategic development of meeting requests
- Panel Meeting Package, Expert Reports, Sponsor presentations
- Identification and management of Subject Matter Experts
- Coordination of Mock Panels, Preparation Workshops, and other Practice Sessions