Pharmacovigilance

    We provide expert safety consulting in the fields of Pharmacovigilance. We constantly update our knowledge of new legislation and provide the services your company needs.

    Safety consulting

    The Good pharmacoVigilance Practices (GVP) states that “Each Marketing Authorisation Holder (MAH) shall have in place a system for the collection and recording of all reports of suspected adverse reactions which are brought to its attention”.
    The MAH also needs to assess if their selected distributors are a potential source of safety information (i.e. reports of adverse reactions, medical enquiries or product quality complaints) and verify how the pharmacovigilance obligations on behalf of the MAH are fulfilled.
    BFC has been providing Pharmacovigilance Services and Medical information Services for a variety of companies since 1992 when the first Vigilance and PSUR obligation came into force. We are confident that we can provide what you need to outsource your pharmacovigilance and Medical Information function.

    Pharmacovigilance experts

    Based on our experience over these years we have reduced the PV outsourcing services to basic PV service modules that either fulfill the need of the Local Drug Safety Unit (DSU) or covering multiple markets and requiring a QPPV system. Feel free to contact us and learn more about these BFC PV service modules.

    Benefits

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    Regulatory Affairs

    Quality Affairs

    Pharmacovigilance

    Market Access Program