FDA Advisory Committees

FDA Advisory Committee PreparationFor innovative life science companies, PharmApprove is the best partner to help “prepare to win” at FDA Advisory Committees.  Our pioneering approach — refined over 18 years’ experience and 200-plus projects — has helped more than 115 clients achieve success at these high-profile, high-stakes hearings. 

No regulatory event is as intense or as challenging as an FDA Advisory Committee. Over the course of a few hours, the fate of your product hangs in the balance as your team faces an onslaught of tough questions from a panel of skeptical clinicians, statisticians and other experts.

Staffed by seasoned Principals, Communications Strategists and Coaches, Slide Presentation Specialists and Project Managers — and supported by a deep bench of over 1000 scientific and regulatory experts — PharmApprove calmly and confidently guides your team to success at this critical, on-the-record public hearing. During the intensive rehearsals leading up to the hearing, we help you crystallize your scientific insights, respond to telling questions, and translate your complex data into the most compelling argument for approval.

Our flagship FDA Advisory Committee Preparation service uses a hands-on approach to give our clients the tools to win; many have called it “the gold standard for hearing preparation.”  Learn more…