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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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.
“3D immerses themselves in your science and strategy to become part of your team. They think outside the box and always deliver a program that has an immediate impact – and an enduring effect – on your team’s communications skills.”
Petra Őrsy
MD Senior Medical Director, Diabetes
Novo Nordisk, SEEMEA
LoOI = List of Outstanding Issues; LoQ = List of Questions