Multi Country QPPV Deployment for PV Compliance

 



Customer Requirement

A large US-based pharmaceutical company with a broad global footprint, multiple manufacturing sites, and an extensive pharmaceutical portfolio needed reliable local pharmacovigilance (PV) compliance support across 11 international markets covering over 30 marketed products. The brands under its portfolio had significant visibility and consumer demand, making any PV non-compliance a high regulatory and reputational risk. To ensure seamless operations, the company’s Global Patient Safety team sought a partner capable of deploying qualified local QPPVs across 11 countries of Middle East and APAC. 

Problem Statement

The client required swift and compliant setup of local PV infrastructure in regions with varying and evolving regulatory expectations. Key challenges included: 

  • Imminent agency inspections demanding urgent compliance readiness 
  • Need to align and integrate local safety teams with the client’s global PV system 
  • Real-time reporting and escalation requirements 
  • Development of inspection-ready documentation and country-specific SOPs 

Timeliness was critical, and the client expected an efficient, structured, and audit-ready mobilization plan. 

FDA Clinical Hold Lifted with DDReg’s Toxicology Expertise

Read more here to know about DDReg Solutions: https://resource.ddregpharma.com/case-studies/qppv-deployment-across-11-countries-for-pv-compliance/  

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