Expert Q&As
First interactions with EMA - Q&A 1
What are the different regulatory pathways available when expanding to Europe and which one is the best fit for me?
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What’s Inside the Q&A:
Pathway Decision Framework
Identify which of the four regulatory routes fits your product type and commercial strategy.
Timeline & Coverage Comparison
Side-by side breakdown review periods, country coverage, and resulting licenses for each pathway option.
Mandatory vs. Optional Routes
Understanding when you have no choice (biotechnology, orphan drugs) versus when you control the decision and timing.
Multi-Pathway Approach
How to combine different pathways (starting with DCP, then using MRP for expansion) for optimal market coverage.
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Launching in EU - Q&A 1
Why is launching a drug in Europe different from launching in the US?
