Our Pharmacovigilance team has the know-how and experience required to perform audits for Pharmacovigilance systems, commercial partners/distributors, subsidiaries, CROs… ensuring compliance with guidelines and normative . We also offer consulting and management during inspections and audits, as well as the definition, implementation and monitoring of CAPA plans.
- Internal audits of the pharmacovigilance system, identifying areas for improvement and advising on the implementation and follow-up of corrective actions
- Support and expert advice on Inspections from Health Authorities, collaborating throughout the process (preparation, implementation and follow-up)
- External audits of subsidiaries, partners and CROs