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.

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

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Is 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.

“CHMP meetings are unlike any other regulatory interaction. Because members cast their vote after the company has left the room, it’s vital that members accept and remember your message. 3D kept us on track and on message – and their technology and coaching kept us engaged with the committee. They were instrumental in helping us!”
Dennis Ahern, Vice President, Global Regulatory Affairs,
Greenwich Biosciences Inc.

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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.

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.

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