All regulatory communications have data.
Successful communications have a story.
Work with 3D to get your story straight from the start.
Maximize the strategic impact of your pre-submission meetings
with the FDA.
Identify and align with FDA on objectives for key clinical milestones.
Obtain clear direction on FDA concerns and priorities.
Convey clinical program progress with a credible scientific narrative.
That’s where 3D comes in. 3D helps you
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Leverage regulatory precedent and scientific materials to anticipate and proactively address potential FDA concerns.
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Write briefing documents and related submission materials that convey a concise and cohesive scientific story.
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Develop Q&A playbooks that drive discussions to address FDA issues and achieve shared objectives.
We work with you to ensure your FDA interactions are focused and constructive, paving the way for efficient clinical development and clear regulatory objectives.
BLA = Biologics License Application; EOP2 = End of Phase 2; IND = Investigational New Drug; NDA = New Drug Application; PMA = Premarket Approval
Our Latest Thinking
- Aligning a Corporate Narrative—and Leaders—for Effective Communications
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Book Review: The CHMP Meeting Survival Manual –
A Step-by-Step Guide to Succeeding at Regulatory Meetings for Marketing Authorization - Book Review: The FDA Clinical Submission Survival Manual
Our proven process 3D ACT® is not magic. It's better.
Learn Why