Pharmacovigilance Audits

Home Services Pharmacovigilance Audits

Pharmacovigilance Audits

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

These audits allow to assess the compliance of the systems in place and of pharmacovigilance with the applicable regulatory requirements, contractual arrangements and procedures.

Our methodology:

  • Definition of your needs to prepare a tailored proposal / contract
  • Audit preparation: kick-off meeting and transmission of documents relevant to the audit
  • Risk-based approach for audit conduct
  • Audit report:
    • Executive summary including an overall assessment
    • Methodology
    • Conduct
    • Audit evidences and 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