EU market entry strategy

Common failure modes that delay EU MAA:

→ No EudraVigilance organization/roles established
→ Article 57 database content misaligned with dossier
→ RMP drafted without clinical evidence integration
→ DSUR narratives disconnected from benefit-risk profile

The companies that avoid these delays start PV preparation in Phase I-II:

✅ Build Development RMP that evolves into inspection-ready RMP
✅ Align signal detection with emerging benefit-risk story
✅ Lock EudraVigilance/xEVMPD fundamentals before MAA clock starts
✅ Establish local QPPV network early (not at submission)

When EMA inspectors review your PV system, they expect documented processes, proactive risk planning, and full traceability from Day 1. Companies that build this foundation early typically launch 3-6 months faster than those consolidating PV data post-Phase III.

For biotechs planning EU expansion: your PV partner should know how to respond to EMA questions about benefit-risk evolution throughout development, not just submit reports.

Ready to avoid the late-stage PV resources black hole?