Pharmacovigilance Audits (GVP)

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Our Pharmacovigilance team has the knowledge and experience required for executing audits to Pharmacovigilance systems, commercial partners/distributors, subsidiaries, CROs… ensuring compliance of the applicable regulation.

 

 

We offer the following services:

  • Counseling and management during inspections and audits, as well as definition, implementation and follow-up of CAPA plans.
  • Internal audits of the pharmacovigilance system, identifying improvement areas and advising in the implementation and the follow-up of the corrective actions.
  • Expert support and counseling in the Inspections of authorities, collaborating during all the process (preparation, execution and follow-up).
  • External audits to subsidiaries, partners and CROs.
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