Regulatory Services
How do you take the blood, sweat, and tears out of regulatory approval?
Call on 3D at every stage of the approval process.
We get you ready to win.
Our scientific and communications experts work with you to pressure-test your data and develop the right story – and coach your team to deliver with confidence.
FDA Advisory Committee MeetingsEMA/CHMP MeetingsRegulatory Communications
Is there really any other option than winning at an FDA Advisory Committee Meeting?
Team up with the best in the business to win.
85% of our clients win FDA approval.
Our people, process, and technology help you stay focused, work smarter, and face your most demanding and skeptical audience.
“3D gave us a turnkey solution to our Advisory Committee preparation challenges. They took a leadership role in creating strategy, executing mocks, developing slides, and providing all of our technology and audio-visual needs – we wouldn’t want to prepare for a meeting without them.”
Amy Tezel, PhD, Vice President,
Global Regulatory Affairs, Alcon
Our Latest Thinking
- When Addressing CHMP Major Objections, Don’t Forget About Benefit-Risk
- Gaining Market Authorisation in Europe: Responding to Complex EMA Questions When You’re on the Clock
- CHMP Meeting Success: Providing Clinical Perspective to Overcome Major Objections
Our proven process 3D ACT® is not magic. It's better.
Learn WhyIs EMA approval critical to your business?
Partner with experts who have been there, done that.
3D brings invaluable insights and experiences to clients on what happens behind closed doors.
Set your team up for success with a strong presentation and persuasive answers at CHMP. Long after you leave the room, make them remember your story to get a positive vote.
“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. Preparing for critical meetings with 3D positions you to finish first!”
Will Lewis, Chairman & CEO,
Insmed
Our Latest Thinking
- When Addressing CHMP Major Objections, Don’t Forget About Benefit-Risk
- Gaining Market Authorisation in Europe: Responding to Complex EMA Questions When You’re on the Clock
- CHMP Meeting Success: Providing Clinical Perspective to Overcome Major Objections
Our proven process 3D ACT® is not magic. It’s better.
Learn WhyStart with the end in mind.
Effective regulatory communication requires a strategic approach that addresses issues early in development and positions your product for success throughout its lifecycle.
Let us help shape your content so it stands up to regulatory scrutiny.
Our full-time team of science and communications experts works alongside you at any stage of the submission process to prepare and deliver clear and persuasive messages to regulatory authorities.
“The 3D team was exceptional. It was the best money I’ve ever spent for the company.”
Jon Hunt, PhD, VP Clinical and Regulatory Affairs,
Cameron Health Inc.
Our Latest Thinking
- When Addressing CHMP Major Objections, Don’t Forget About Benefit-Risk
- Gaining Market Authorisation in Europe: Responding to Complex EMA Questions When You’re on the Clock
- CHMP Meeting Success: Providing Clinical Perspective to Overcome Major Objections
Our proven process 3D ACT® is not magic. It’s better.
Learn Why