All regulatory communications have data.
Successful communications have a story.
Work with 3D to get your story straight from the start.
Stay in control of your submission with timely, strategic responses
to FDA Information Requests.
Translate FDA questions into clear, persuasive answers.
Align your responses with your product’s core regulatory and clinical narrative.
Minimize the back-and-forth with FDA that can stall your submission.
That’s where 3D comes in. 3D helps you
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Coordinate and integrate input from different functions to ensure answers are strategic, consistent, and on message.
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Anticipate and address reviewer concerns to reduce the risk of follow-up requests, CRLs, or Advisory Committees.
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Respond to complex FDA questions quickly—with precision, clarity, and credibility.
We work with you to develop FDA IR communications that are focused on advancing your submission—so you maintain momentum and avoid missteps.
Our Latest Thinking
- 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
- CHMP Meeting Success: Providing Clinical Perspective to Overcome Major Objections
Our proven process 3D ACT® is not magic. It's better.
Learn Why