Pharmacovigilance Audits

PharmaLex’s organization ensures global delivery of all Pharmacovigilance  audit services. We are the first-choice provider of Pharmacovigilance audits for many pharmaceutical companies around the world. At PharmaLex, auditors are highly qualified with necessary and long-standing expierence as well as strong cultural awareness and excellent communication skills to effectively conduct and/or participate in PV audit activities.

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    Our Pharmacovigilance Audit Services

    PharmaLex offers a full range of Pharmacovigilance audits services in line with GVP requirements and global regulations. Our team accompanies you from the designing and implementation of PV audit system to follow-up activities and support in case of inspections.

    Design and implentation of PV audit system:

    • Support for defining and implementing risk-based audit strategy
    • PV audit risk analysis
    • Preparation and management of PV audit program
    • Preparation and management of PV audit questionnaire

    PV audit support:

    • PV system GAP analysis
    • PV audits at or on behalf of client company:
    • PV System internal audits
    • Affiliate audits
    • License partner/distributor audits
    • Qualification of PV vendor audits
    • Process audits (PSMF, RMP, PSUR…)
    • Due diligences
    • PV inspections support

    Follow-up activities:

    • Preparation, management and follow-up of CAPA plan related to PV audits or inspections


    We offer global solutions covering the entire product lifecycle

     Our solutions, consisting of core services, which are tailored to address each of your unique requirements. Extensive program management expertise is a key success factor within our service solutions.

    Effectiveness with confidence, compliance and flexible solutions

    To comply with the legislation applied to our global Pharmacovigilance (PV) market, the Marketing Authorisation Holder of medicinal products must have a PV system in compliance with all applicable regulations. PV audits are meant to review the existing PV system and to establish its compliance with regulatory PV obligations. PharmaLex has key competence in implementation of PV audit systems, CAPA management and PV inspection support. Our team can help you to verify the effectiveness of the implementation of your PV and quality systems.

    Customized Pharmacovigilance Audits

    PharmaLex has a wide-ranging pharmacovigilance compliance experience to accommodate the very different needs for pharmaceutical and medical device companies. Our auditing team studies the organizational structures of your company, portfolio, legal requirements and agreements to personalise all PV audit service and tailor to your needs. PharmaLex has technical set-up, know-how and great experience for remote auditing. Our aim is to conduct the audit in a way that allows you to move forward in every interaction. We offer onsite and remote audit according to your preferences.

    Available Resources

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    Global Approach

    PharmaLex has 60+ offices in 32 countries serving more than 1600 satisfied clients worldwide. Search your nearest office.

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