From Decentralized to Audit-Ready: Transforming PV Operations for 150+ Products

A specialty pharmaceutical company with more than 150 medicinal products selected PrimeVigilance to provide full-service global and local PV support. The transition aimed to replace a decentralized operating model with a more efficient, transparent and centralized approach.

During the transition, PrimeVigilance identified gaps in local operations, limited oversight and inconsistencies in documentation and quality control — with two EU regulatory inspections and an internal PV audit approaching

Key outcomes 

• 150+ medicinal products successfully transitioned
• Global and local PV activities brought into a full-service outsourcing model
• Local PV responsibilities streamlined and aligned with legislative requirements
• Documentation gaps addressed and identified risks mitigated to support audit readiness

How Do You Transition 150+ Products Without Compromising PV Continuity?

Download the case study to see how PrimeVigilance used centralized oversight, early gap identification and structured vendor collaboration to transition a complex PV portfolio while strengthening audit readiness.