Coordinating Local RA & PV Support Across 18 EU/EEA Countries

A client preparing for market launch needed local Regulatory Affairs and Pharmacovigilance support across multiple EU/EEA countries within short timelines. The project covered more than 300 Marketing Authorizations and 100+ individual dossiers and required LCPPV, LCPRA, LCPQA and PRLS services alongside country-specific regulatory expertise.

PrimeVigilance established a coordinated local network across 18 EU/EEA countries to support the client’s launch and compliance requirements.

Key outcomes 

• Support coordinated across 18 EU/EEA countries
• 300+ Marketing Authorizations covered
• 100+ individual dossiers supported
• Local RA, PV, QA and PRLS expertise coordinated through one network
• Products successfully launched within the agreed timeline

How Do You Coordinate a Time-Sensitive Launch Across 18 Countries?

Download the case study to discover how PrimeVigilance brought together local regulatory and pharmacovigilance expertise to support a complex, multi-country European market launch.