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.