• Pharmacovigilance Self-Inspections and Gap Analyses
  • GVP Inspection Preparation and Assistance

Our experienced auditors conduct pharmacovigilance system inspections designed to assess compliance with regulatory pharmacovigilance obligations and inspection readiness of Client’s procedures, systems, personnel and facilities. The Certus PV team also conducts targeted customized product-related pharmacovigilance audits focused on product-related issues, including product-specific activities and documentation.

Our experienced auditors conduct pharmacovigilance system inspections designed to assess compliance with regulatory pharmacovigilance obligations and inspection readiness of Client’s procedure.
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We prepare our clients for routine Good Pharmacovigilance Practices (GVP) inspections, as well as ‘for cause’ pharmacovigilance inspections by regulatory authorities and provide post-inspection assistance.  Our expert auditors also guide organizations going through follow-up inspections for identified non-compliance issues, by establishing corrective and preventive action plans and periodic progress reports, as required.