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    GVP Audits (remote and on site)

    Pharmacovigilance legislation established a legal requirement for MAHs to perform audits of their pharmacovigilance systems, including risk-based audits of their quality systems.

    According to GVP Module I, an audit is a systematic, disciplined, independent and documented process for obtaining evidence and evaluating the evidence objectively to determine the extent to which the audit criteria are fulfilled, contributing to the improvement of risk management, control and governance processes.

    Pharmacovigilance audit activities should verify, by examination and evaluation of objective evidence, the appropriateness and effectiveness of the implementation and operation of a pharmacovigilance system, including its quality system for pharmacovigilance activities.

    You can outsource GVP audits to SciencePharma, who has already performed hundreds of audits for both local and foreign Clients.

    Our GVP audits services include among others:

    • Remote and on-site PhV audits
    • PhV audits of Local Points
    • Support during PhV Inspections performed by the EU or non-EU Agencies.

    What makes us the best? Being a PhV provider for almost 2 decades, we are systematically audited and inspected. This allows us to gain experience, be up to date with all GVP requirements and ensure that we are in constant audit readiness.

    How can we help You?

      Please be advised that the administrator of personal data entered in the above form is SciencePharma Sp. z o.o. with its registered office in Warsaw, Chełmska 30/34. These data are processed in order to receive incoming correspondence and respond to it. Providing personal data is voluntary, but necessary to send the form. Each person has the right to access their data and correct it.

      You can read the details on the protection of personal data here.