Post-Approval Maintenance

Whether you are interested in outsourcing portfolio maintenance, require support during a merger and acquisition phase, need assistance covering your pharmacovigilance obligations or in development and implementation of your QMS—our Post-approval solutions provide trusted, strategic ways, as well as hands-on support, to keep your product compliant and moving forward.


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    Seamless Support

    After a medicinal product has obtained Marketing Authority (MA,) it is authorized for commercial use. However, maintenance obligations must continue to be met in all regulated areas.

    To retain Marketing Authorization, the MA holder must continually:

    • Update work to ensure the approved dossier is valid
    • Address safety surveillance issues by having pharmacovigilance systems in place
    • Implement and maintain quality management / assurance systems to deal with developments such as changes in the manufacturing of the product and relevant changes in the company’s settings
    • Respond to renewal requirements, as necessary

    Challenges that accompany large product portfolios, differing global markets, evolving regulatory landscapes, and stakeholder expectations can further increase the complexity, unpredictability and intensity of the Post-approval Phase.

    Changes in development and regulations require continuous updates to systems, documents and agreements. Consequently, time and resources may be strained, causing new product development to suffer.

    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.

    Available Resources

    Smart Technology + Savvy Humans = Brilliant Solutions

    With over 33 offices around the globe, our highly specialized network customizes optimal, region-specific solutions for the Post-approval Phase.

    Emerging Smart technologies employ computerized and automated service lines, including our PharmaLex Partnerships database, to free up time and resources—so you can focus on what is important.

    Discover technology that helps you:

    • Orchestrate all global activities for GxP management within a single cloud solution
    • Automate case processing and safety literature
    • Audit incoming case safety reports
    • Manage pharmacovigilant agreements
    • Transition to a fast, holistic solution for paperless compliance
    • Evaluate possibilities with the Risk Assessment Tool for Excipients (RATE)
    • Analyze GxP vendor metrics

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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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