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Pharmacovigilance Auditing

Medwork’s auditing process is similar to the approach taken by the EU Competent Authorities. We offer a very well-structured, low-budget pharmacovigilance audit programme in compliance with EU legislation. We perform pharmacovigilance system audits of main functions, affiliates and contractual partners.

We can support and coach Marketing Authorization Holders before and after regulatory inspections. We perform mock inspections to ensure adequacy and compliance of pharmacovigilance systems.