Pharmacovigilance Audits

PVCON delivers comprehensive pharmacovigilance audits designed to evaluate the effectiveness, compliance, and maturity of your PV systems against global regulatory expectations including EU GVP, FDA 21 CFR, and ICH E2E guidelines. Our experienced auditors assess global PV systems, local affiliate operations, business partner arrangements, and service provider oversight frameworks.

Our PV audit methodology covers the full spectrum of pharmacovigilance operations — from signal detection and ICSR processing to PSMF maintenance and aggregate reporting. We conduct audits of MAH systems, distributor and MRP/PSP vendor arrangements, and local affiliate PV compliance to identify gaps before regulators do.

Beyond audit execution, PVCON provides risk-based audit planning, CAPA strategy development and tracking, PV system gap analysis, mock inspections, and internal auditor training. Our goal is to transition your organization from reactive compliance to continuous inspection readiness across all pharmacovigilance operations.