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

Establish open and constructive communications with EMA-CHMP.
Develop a clear, consistent scientific narrative supporting EU approval.
Submit compelling written responses to EMA Day 120 / 180 requests.

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

• Proactively identify potential actions and analyses that address questions.

• Develop responses that address questions and issues while bridging back to key approval messages.

• Facilitate collaboration with functional experts to enhance written responses that resolve major objections.

We work with you to resolve EMA concerns during MAA review—so you achieve marketing authorization in the EU.

 

_{LoOI = List of Outstanding Issues; LoQ = List of Questions}

Our Latest Thinking

• New Survey of 400+ FDA Advisory Committee Members Weigh in on Recommendations for Reforms
• Every Speech is an Opportunity for Greatness. Seize It.
• Public Comment: Optimizing FDA’s Use of and Processes for Advisory Committees

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

Learn Why

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How We Work