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?
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What’s Inside the Q&A:
Pathway Selection Pitfalls
Why choosing the wrong regulatory route especially for biotech products can delay approval and waste time.
Dossier Preparation Best Practices
Key EMA-specific requirements (like RMPs, multilingual labeling, and PIPs) that must be addressed early to avoid validation failures.
Clock Stop Management
How to plan ahead for EMA’s milestone-based reviews, ensuring your team is ready to respond quickly and completely.
Strategic Use of EU Designations
When and how to leverage Orphan, PRIME, and accelerated assessment pathways—distinct from U.S. fast-track programs.
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