Pharmacovigilance Audits

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Pharmacovigilance Audits

To comply with regulatory requirements as a Marketing Authorisation Holder / "Exploitant", Sunnikan realises audits of your Pharmacovigilance system: Corporate, Affiliate, Partner, Distributor, including corresponding quality management system.

These audits allow to assess the systems in place for pharmacovigilance activities regarding regulatory requirements and applicable procedures.

Our methodology:

  • Definition of your needs to prepare a tailored proposal / contract
  • Audit preparation: kick-off meeting and transmission of documents relevant for the audit
  • Risk-based approach for audit conduct
  • Audit report:
    • Executive summary including an overall assessment
    • Methodology
    • Conduct
  • Audit evidences
    • Findings (with criticality assessment: minor, major, critical)
    • On request: improvement suggestions
  • Preparation and review of the CAPA Plan (as applicable).

Sunnikan draws up audit programs that are perfectly adapted to the needs and obligations of its Clients..

Request for a proposal