All regulatory communications have data.
Successful communications have a story.
Work with 3D to get your story straight from the start.
Obtain critical recommendations from advisory panels for your MAA.
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
“I wish to thank 3D for their outstanding operational support, dedication to the project, and quality of expert input. Job really well done. I’d recommend them for anyone preparing for a SAG or OE.”
Lynn Kramer MD, FAAN
Chief Clinical Officer, DHBL
Eisai Co., Ltd.