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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Expert Q&As
First interactions with EMA - Q&A 6
What CMC (Chemistry, Manufacturing, and Controls) expectations in the EU might surprise biopharma companies?
Expert Q&As
First interactions with EMA - Q&A 5
How should we approach pricing and reimbursement across EU countries?
Expert Q&As
First interactions with EMA - Q&A 7
What regulatory pathway missteps should we avoid, and how can we streamline our EU dossier preparation?
