FDA Advisory Committee Meeting Preparation Services

We’re Here To Help

FDA Advisory Committee Meeting Preparation Services

The stakes are sky-high at an FDA Advisory Committee meeting.

You’ve spent years developing your product. Now you’ve got just one chance to make your case for it. And the outcome can make or break your product — even your company.

PharmApprove can prepare you for the challenges of that day

PharmApprove is the pioneer in Advisory Committee preparation. Our rigorous approach — developed over more than 150 public hearings — will help your team and your Briefing Documents, presentations and responses to questions make the most compelling case for your product.

Our team of project leaders are industry professionals and communication coaches with decades of scientific communication experience. We will help you prepare your content (“what you say”) and will train you on persuasive and powerful delivery (“how you say it”).

Why choose us for this service?

PharmApprove is the acknowledged leader in FDA Advisory Committee preparation. We’ve been helping global companies make the best possible case for their products since 1999.

In the past five years alone, we’ve helped over 60 applicants through Advisory Committees in almost every therapeutic area. We’ve also tackled priority reviews, orphan indications, and other complex, high-profile hearings.
The result? A “win rate” of over 80%.

If you’re developing a product in the US and Europe, PharmApprove provides unparalleled synergistic support on both sides of the Atlantic.

How can we support you?

Preparing for an FDA Advisory Committee can take up to six months. But we’ll guide you every step of the way with a full suite of services scaled to fit your specific needs. Those services include:

Strategy Development

  • Advisory Committee Strategy
  • Advisory Committee Intelligence
  • Mock Panel Recruitment
  • Mock Panel and Team Session Facilitation

Scientific Messaging

  • Key Messages and Storyline
  • Briefing Document
  • Core Presentations
  • Q&A Preparation

Training & Preparation

  • Presentation Development
  • Presentation Coaching
  • Q&A Training
  • Slide Creation, Indexing & Retrieval
  • Technology and A/V Production

Project Execution

  • Team Organisation
  • Project Management
  • Meeting Logistics
  • Open Public Hearing Coordination