All regulatory communications have data.
Successful communications have a story.
Work with 3D to get your story straight from the start.
Build and execute the negotiation strategy for your product label.
Understand what may drive or derail labeling negotiations.
Map and test your negotiation strategy.
Communicate effectively during FDA negotiation meetings.
That’s where 3D comes in. 3D helps you
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Analyze labeling precedent and anticipate likely FDA challenges.
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Develop a label negotiation roadmap and supporting content that aligns with path to desired labeling.
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Prepare for label negotiations with realistic mock meetings.
We work with you to achieve an effective US product label.
"Negotiating a label with the FDA is a high-stakes, highly sensitive endeavor. 3D worked with us to develop a comprehensive strategy, prepare for potential scenarios, eliminate regulatory barriers, and craft a solid scientific story – ensuring we secured the best possible package insert. Their team and expertise are unparalleled."
Todd Gross, PhD
Head of Clinical Development & Biostatistics
Allergan, Medtronic Diabetes, Kythera, and Revance Therapeutics Inc.