Advisory Committee Preparation
No regulatory event is as intense as a FDA Advisory Committee meeting. You have one chance to get it right.
PREPARE TO WIN
Data never speaks for itself
Over the course of a few hours your team must present an argument for approval, supported by data, and then face an onslaught of tough questions from a panel of skeptical experts. We know that most products rejected by the committee also are rejected by the FDA.
You need to find the best partner to manage the process, align your team and arm you with the tools to prepare to win.
Advisory Committee clients
Presenters & responders coached
What we do
Focus on what’s important
Preparing for an FDA Advisory Committee is a major undertaking for your company. Most teams spend six months getting ready to deliver and defend a cohesive and meaningful story grounded in data.
In our 20 years of helping companies prepare for their Advisory Committee meeting we’ve learned that the two most important factors for success are team alignment and rigorous preparation. To that end, we become an extension of your team, doing the hard work with you and taking the pressure off.
We are a full-service provider for Advisory Committee preparation. To tell the story and guide the committee you’ll need strong scientific support, project management, data visualization design, and technology that enhances the productivity of your team. From the early stages of intelligence gathering, through to the final exhausting hours, our team becomes part of your team. We work as close colleagues, with you and your management, to ensure organizational alignment and prioritization of the preparation efforts.
Our breadth of capabilities and depth of expertise mean we can quickly get up to speed on your drug product or device and achieve unprecedented outcomes. We supplement your team’s expertise and bring fresh, unbiased perspective. When time is of the essence, we can quickly recruit additional experts from our extensive network, to provide strategic advice, expand your voice and refine your message.
I’ve seen a lot of organizations during my lifetime in pharma, and PharmApprove is by far the most impressive. Your ability to steer the group in a calming manner was awesome.
FDA guidance on Advisory Committees
If you want to learn more about FDA Advisory Committee meetings we recommend a visit to the FDA web page on FDA Advisory Committees at FDA.gov.