“3D has worked on both FDA and European regulatory approvals.

They helped drive the presentation process, then rolled up their sleeves and helped us do the work.

They’re relentless -- THE BEST at what they do – and they helped us be the best.”

Sue James
VP Regulatory Affairs, Compliance
GSK Consumer Healthcare
 

 

We Wrote the Book!

The FDA Advisory Committee Meeting Survival Manual

A Step-by-Step Guide to Preparing for a Successful FDA Advisory Committee Meeting.

FDA Submissions & Advisory Committee Meeting Preparation

Experience winning FDA approval.

Going before the FDA or an FDA advisory committee is one of the most important presentations a pharmaceutical, biotech, or device company will ever make.

After years of development, and hundreds of millions of dollars, it all comes down to one day – and there’s no second chance.

At 3D, we know the FDA.

Through our proprietary 3D ACT™ services, we work side-by-side with teams to:

  • Review Scientific Data
  • Profile FDA Advisory Committee Members
  • Set Strategy
  • Create Messages
  • Develop the FDA Presentation Outline
  • Write the FDA Presentation
  • Create and Call Up Slides
  • Write Qs and As
  • Role-Play Participants on Camera