From Regulatory Gaps to Inspection-Ready Operations Across 56 Countries

A global pharmaceutical company inherited a fragmented PV framework across Africa and Asia, with missing or non-compliant Local Pharmacovigilance System Master Files (L-PSMFs) creating significant compliance exposure. PrimeVigilance coordinated Regulatory Intelligence, Local QPPV and Project Management expertise to address local requirements and establish a scalable compliance framework.

Key outcomes 

• Compliance framework established across 56 countries
• Country-specific L-PSMF requirements addressed
• Enhanced inspection readiness across affected markets
• Regulatory inspections completed with no major or critical findings

See How Compliance Was Scaled Across 56 Countries

Download the case study to discover how PrimeVigilance combined local regulatory expertise with centralized governance to transform fragmented operations into an inspection-ready compliance framework.