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.

FDA Advisory Committee Meetings

Is there really any other option than winning at an FDA Advisory Committee Meeting?

Team up with the best in the business to win.

fda building

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

Is EMA approval critical to your business?

Partner with experts who have been there, done that.

ema chmp

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

Start 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.

Regulatory Communications

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.

Regulatory Services at Your Fingertips

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