All regulatory communications have data.
Successful communications have a story.

Communicate compelling arguments for key issues or questions.
Align with experts on recommendations favoring MAA approval.
Clarify key elements of your scientific narrative to the EMA-CHMP.

That’s where 3D comes in. 3D helps you

• Establish clear messaging around complex scientific issues.

• Create briefing materials, scripted presentations, and Q&A content.

• Test content with external experts who mirror your anticipated audience.

We work with you to set the stage for regulatory success with positive recommendations from EMA-CHMP advisory groups.

 

_{AHEG = Ad Hoc Expert Group; PRAC = Pharmacovigilance Risk Assessment Committee; SAG = Scientific Advisory Group}

Our Latest Thinking

• 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
• New Survey of 400+ FDA Advisory Committee Members Weigh in on Recommendations for Reforms

Our proven process 3D ACT^® is not magic. It's better.

Learn Why

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