At Dr. Mwiko Health Solutions Ltd, we provide comprehensive pharmacovigilance (PV) audit and compliance support that aligns with Good Pharmacovigilance Practice (GVP) requirements and international regulatory standards. We assists clients throughout the entire audit cycle from the development of a risk-based PV audit framework to post-audit follow-up and inspection readiness support.
PV Audit System Design and Implementation
- Development and execution of risk-based pharmacovigilance audit strategies
- Conducting PV risk assessments and audit planning
- Designing and managing annual PV audit programmes
- Creating and optimizing audit tools and checklists tailored to client operations
Pharmacovigilance Audit Support
- Performing PV system gap assessments and compliance reviews
- Executing internal PV system audits for marketing authorization holders
- Conducting audits of affiliates, license partners, distributors, and third-party vendors
- Carrying out process-specific audits (e.g., PSMF, RMP, PSUR, signal management)
- Supporting due diligence reviews during mergers, acquisitions, or partnerships
- Providing strategic assistance and representation during regulatory inspections
Post-Audit and Inspection Follow-Up
- Development, tracking, and closure of CAPA (Corrective and Preventive Action) plans
- Continuous monitoring to ensure sustained compliance and quality improvement
