What regulatory pathway missteps should we avoid, and how can we streamline our EU dossier preparation?

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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.