All regulatory communications have data.
Successful communications have a story.
Work with 3D to get your story straight from the start.
Address issues and questions effectively to mitigate
potential major objections.
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
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Proactively identify potential actions and analyses that address questions.
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Develop responses that address questions and issues while bridging back to key approval messages.
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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
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Our proven process 3D ACT® is not magic. It's better.
Learn Why