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"3D has worked on both FDA and European regulatory approvals. They helped drive the preparation process, then rolled up their sleeves and helped us do the work. They’re relentless - THE BEST at what they do – and they helped us be the best!"
Sue James
VP Regulatory Affairs, Compliance, Quality
GSK Consumer Healthcare
"3D Communications is a top company in a complex scientific and regulatory field. They analyzed our committee members and expertly matched each one with a mock advisor to form the most incredible group of Key Opinion Leaders we ever worked with."
Mary Ann McElligott, PhD
Associate Vice President, Regulatory Affairs
Novo Nordisk

ADCOM RADAR and MATCH.MOCK are trademarks of 3D Communications.





3D ACT™ (Analysis, Content Development, Testing) Process for FDA Advisory Committee Meetings

ANALYSIS
3D will work with you to clearly identify your long-term goals, product positioning, and specific objectives for each meeting. We help teams focus on what they want to achieve, anticipate regulatory questions and concerns, and formulate a plan for success.

We will use  our ADCOM RADAR® process to  analyze your advisory committee, helping sponsors develop messages, create presentations, predict questions, and prepare answers that will satisfy committee members and resonate with the FDA.

CONTENT DEVELOPMENT
3D scientists and seasoned scientific writers will work with you to translate complex data into clear messages that put the science in context.  We’ll also help you develop data-driven answers to tough questions and compelling slides. Using Mind Mapping and the 3D Message Pyramid™, we ensure the data are woven into a clear and comprehensive presentation that informs and persuades.

TESTING
One of the best investments of time and money in the preparation process is to convene a mock advisory committee of outside experts.  3D approaches these mock rehearsals from the perspective that “Practice does not make perfect – only perfect practice makes perfect.”  (Vince Lombardi)

We build your mock advisory panel by searching KOLLEAD®, our proprietary database of experts who have served on past FDA advisory committees. Then, through our MATCH.MOCK® process, we select mock panelists for their experience and ability to examine, interpret, and challenge the data similarly to the actual members your team will face.

The result:   Your team will be confident, credible, and poised to succeed at each regulatory interaction. 

 




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