Pharmacovigilance Audits

Biomapas offers Pharmacovigilance (PV) audits to evaluate the appropriateness and effectiveness of your pharmacovigilance (PV) system.

Our well-trained auditors with a proven track record keep an objective, independent mindset when inspecting evaluate your system’s implementation and operations. Usually, our professionals take on EU Qualified Persons for Pharmacovigilance (QPPV) roles and have solid credentials in global PV operations. A combination formula that allows them to understand the technical and practical aspects and provide you with improvement options.

Our professionals have unrivalled expertise in conducting remote or on-site audits across all aspects of your PV system, including audits of:

• company headquarters & affiliates
• license partners
• vendors & distributors

Additionally, we implement a risk-based approach to develop and provide you with audit strategies that entail an effective program and a sound CAPA management system.

Our trainers can also provide inspection readiness training, mock audits, interview practice and enhance your inspection readiness to prepare your staff optimally for upcoming audits.