All regulatory communications have data.
Successful communications have a story.
Work with 3D to get your story straight from the start.
Strengthen your responses and expand your discussions with
CHMP to resolve issues blocking your product’s authorization.
Understand the CHMP’s underlying concerns behind their questions and objections.
Tackle their scientific and regulatory concerns head-on.
Expand your messages and supporting data to highlight your product’s benefit.
That’s where 3D comes in. 3D helps you
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Leverage Day 120 / 180 requests, Joint Assessment Reports, and regulatory precedent to guide your response strategy.
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Craft clear, consistent responses and integrate key messages and relevant data into meeting scripts.
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Prepare for tough questions with tailored mock sessions and focused rehearsals.
We work with you to maximize every CHMP interaction—so your messages gain momentum towards authorization.
Our Latest Thinking
- Path to CDRH Approval: Practices and Preferences of FDA Medical Device ADCOM Members
- Preparing for Regulatory Submission: Analyzing Clinical Data to Strengthen the Benefit-Risk Profile
- Post-Marketing Plans: An Often-Overlooked Component of FDA Advisory Committee Meeting Discussions
Our proven process 3D ACT® is not magic. It's better.
Learn Why