Good Pharmacovigilance Practice - Performance and Patient Protection

Good Pharmacovigilance Practice is the minimum standard for continuously monitoring, collecting product safety information, and providing patients, healthcare professionals, and the general public with timely information about adverse effects.

Pharmatek provides a patient-centric, responsive, and agile pharmacovigilance services to our clients. Our global experts in pharmacovigilance systems bring unique capabilities to provide one stop solutions for pharmacovigilance audits to accommodate their various needs.

At Pharmatek, auditors are highly qualified and possess a strong cultural awareness to effectively conduct and participate in GPV audit activities.

Pharmatek provides a risk-based pharmacovigilance audit service, which focuses on the areas of highest risk to an organization’s pharmacovigilance system, while adhering to applicable local regulatory requirements. The depth of our experience with pharmacovigilance audits spans all key functions including system/process, affiliates, service providers and licensing partners for case process, safety management, aggregate reporting, signal detections, literature management, and review.

Our pharmacovigilance experts have coordinated and hosted inspections across major regions for global regulatory authorities including USFDA, MHRA, EMA, Swiss Medic, Health Canada, and PMDA.

Our range of Pharmacovigilance audits services include:

  • Vendor Qualification Audits.
  • System/Process (PSMF, RMP, PSUR etc.,)
  • Affiliates audits
  • Vendor due diligence audit
  • License Partner / Distributor audits
  • Safety system audit

All audit schedules and content are customized to meet our client’s needs. Our audit service workflow includes robust planning, scheduling/notification, preparation, conduct, and reporting. We also provide response review and CAPA assessment, including CAPA effectiveness verification to ensure that any findings are addressed and resolved.

Pharmatek Solutions Inc
Pharmatek Solutions Inc