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.

• Submit compelling written responses to Day 120 / 180 / 195 questions.

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

• Taking the Proactive Path to Approval – The Strategic Advantage of Early Messaging in FDA Submissions
• 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

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

Learn Why

Regulatory Communications at Your Fingertips

How We Work