All regulatory communications have data.
Successful communications have a story.

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 

• Coordinate and integrate input from different functions to ensure answers are strategic, consistent, and on message.

• Anticipate and address reviewer concerns to reduce the risk of follow-up requests, CRLs, or Advisory Committees.

• 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

• Tips for Medical Science Liaisons: It’s Not Only About How Much You Know
• How to Maximize Your FDA Advisory Committee Preparation Team Regardless of Size
• Six Ways to Keep Your Team Motivated During ADCOM Preparation

Regulatory Communications at Your Fingertips

How We Work