A Top 10 Global Biopharmaceutical Company faced increasing regulatory scrutiny and needed to strengthen its Pharmacovigilance (PV) quality systems worldwide.
The project included 15+ global PV audits across 9 months, addressing inconsistent PV practices across affiliates, gaps in SOPs and training documentation, and risks of major findings during upcoming health authority inspections.
Vigilare executed a structured PV Quality Assurance program that included risk-based audits, CAPA implementation, harmonized SOPs, and inspection readiness workshops.
Key achievements included the execution of over fifteen global PV audits within nine months, resulting in improved audit readiness and fewer regulatory findings. Vigilare developed a harmonized PV Quality Management System, reduced audit cycle time by forty percent, and strengthened compliance ownership across teams and partner CROs, ultimately reinforcing a culture of quality and regulatory excellence
Download the case study to see how Vigilare helped this global leader enhance compliance and regulatory confidence.