All regulatory communications have data.
Successful communications have a story.
Work with 3D to get your story straight from the start.
Beat the odds and win at your FDA Advisory Committee meeting.
Only the toughest projects go before an FDA Advisory Committee.
Not a problem. We have you covered. Our people, process, and technology help you stay focused, work smarter, and succeed with your most demanding and skeptical audience.
“Only use 3D if succeeding at an FDA ADCOM is essential. We’ve worked with them on every one of our advisory committees for the last 12 years. Their expertise, process, and work ethic are unmatched.”
Senior Vice President of Clinical, Medical, and Regulatory Affairs, US
Our Latest Thinking
- When Addressing CHMP Major Objections, Don’t Forget About Benefit-Risk
- Leveraging Communications To Help A Nonprofit Stand Out And Motivate Donors To Give – And Give Some More – To The Cause
- Gaining Market Authorisation in Europe: Responding to Complex EMA Questions When You’re on the Clock
Our proven process 3D ACT® is not magic. It's better.Learn Why
Open the door and win at your CHMP meeting.
Presenting at closed-door CHMP meetings can be a daunting
That is, unless you partner with experts who have been “in the room” at CHMP. We’ll
help you develop and deliver a strong presentation and persuasive answers, so you
leave a positive impression with the committee as they discuss your product and decide its fate.
“3D was key to our success during our CHMP Scientific Advisory Meeting and Oral Explanation. Their awesome team effectively led, partnered, scrutinized our thinking, and improved our outcomes – daily.”
Chairman & Chief Executive Officer
Get your regulatory strategy on track from the very beginning.
Waiting for regulatory challenges to happen is a bad strategy.
Let us help you anticipate issues and shape your content, so it stands up to regulatory scrutiny. We work alongside you at every stage of the submission process to prepare and deliver clear and persuasive messages to regulatory authorities.
“3D’s science and regulatory experts partnered with us to synthesize years of complex data – transforming it into a clear and cohesive scientific story for our submissions.”
Michael Rozycki, PhD
Senior Vice President, Regulatory Affairs
Pacira Biosciences, Inc.
Our Latest Thinking
- Five Steps to Delivering an Effective Presentation at an FDA Advisory Committee Meeting
- Preventing and Accounting for Missing Clinical Trial Data for FDA Drug Approvals. Part 1: Prevention
- Preventing and Accounting for Missing Clinical Trial Data for FDA Drug Approvals. Part 2: Analysis
Our proven process 3D ACT® is not magic. It’s better.Learn Why
How Can We Help You?Get Started
Extraordinary times call for extraordinary communications.
We transform the way you communicate.