A practical guide for first-time biopharma applicants entering the EU market.

Filing for EMA marketing authorisation is complex—especially for companies navigating it for the first time. This guide explores six frequent missteps that can delay or jeopardize approval.

What you'll learn:

• Why early engagement with EMA and local agencies is non-negotiable

• How misunderstanding centralized procedures can derail timelines

• What a complete, high-quality dossier should look like

• The benefits of early Orphan/PRIME designation

• Why planning for realistic timelines and PIP compliance is essential

Each section includes real-world examples, EMA references, and practical tips to help regulatory and strategic teams improve their chances of a smooth, successful submission.