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

• Public Comment: Optimizing FDA’s Use of and Processes for Advisory Committees
• Webinar: Taking Q&A with Regulators to the Next Level
• Webinar: CHMP OEs and FDA ADCOMs – Navigating the Differences to Prepare for Success

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

Learn Why

Regulatory Communications at Your Fingertips

How We Work