All regulatory communications have data.
Successful communications have a story.
Work with 3D to get your story straight from the start.
Build a clear and comprehensive clinical story
for your regulatory submission.
Develop a strategic framework aligned with FDA requirements.
Write compelling clinical modules that clearly communicate your data.
Evaluate and refine your modules with feedback from external experts.
That’s where 3D comes in. 3D helps you
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Capture key data and analyses to drive overall benefit-risk of clinical program in modules 2.5, 2.7.3, and 2.7.4.
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Ensure the narrative reflects likely topics and issues for the FDA review team—and future regulatory audiences like FDA advisory committees.
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Seek insights from key opinion leaders throughout the review cycle so you stay on message and on strategy.
We work with you to ensure your clinical modules for regulatory submissions put you on a solid path to regulatory approval.
“3D’s science and regulatory experts partnered with us to synthesize years of complex data—transforming it into a clear and cohesive scientific story for our submissions.”
Michael Rozycki, PhD
Senior Vice President, Regulatory Affairs
Pacira Biosciences, Inc.
ADCOMs = Advisory Committee Meetings; BLA = Biologics License Application; NDA = New Drug Application; PMA = Premarket Approval
Our Latest Thinking
- Taking the Proactive Path to Approval – The Strategic Advantage of Early Messaging in FDA Submissions
- Book Review: The FDA Survival Manual – A Step-by-Step Guide to Preparing for a Successful ADCOM, 2nd Edition
- Pink Sheet: Current, Former US FDA Adcomm Members' Reform Idea: Allow Conflicted Experts To Participate
Our proven process 3D ACT® is not magic. It's better.
Learn Why