Good Pharmacovigilance Practice (GVP) is the minimum standard for continuously monitoring, collecting and providing patients, healthcare professionals, and the general public with timely information about the safety of medical products.

Pharmatek feel pride to provide patient centric responsive and agile services to our clients. Our global experts in pharmacovigilance system and quality domain bring unique capabilities to provide one stop solutions for pharmacovigilance audits to accommodate the various needs of pharmaceutical and medical device companies.

At Pharmatek, auditors are highly qualified with necessary and long-standing experience as well as strong cultural awareness and excellent communication skills to effectively conduct and/or participate in PV audit activities.

Pharmatek provides a risk-based pharmacovigilance audit service, which focuses on the areas of highest risk to an organisation’s pharmacovigilance system, taking into account applicable local regulatory requirements. The depth of our experience with pharmacovigilance audits are across the globe and across all key functions including system/process, affiliates, service providers and licensing partners for case process, safety management, aggregate reporting (AR), signal detections, literature management and review etc.

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

 

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 agreed with the client before being conducted. Our audit service workflow includes a robust planning, scheduling/notification, preparation, conduct, reporting. We do also support response review and CAPA assessment including CAPA effectiveness verification to ensure that the findings are  adequately addressed and resolved.