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    BIGGSB GLOBALAGENT VIEW

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    Clinical & Pre-Clinical Support

    BiggsB supports drug development programs from pre-clinical work through submission and post-market obligations. We help sponsors plan and oversee studies, prepare regulatory submissions, and run clinical operations with the quality discipline regulators expect.

    Service ID
    clinical-preclinical
    Topic
    clinical and pre-clinical regulatory support
    Source page
    https://biggsb.com/services/clinical-preclinical
    Contact
    Discuss this service · connect@biggsb.com

    Who it is for

    • Emerging biotech and pharmaceutical sponsors without a full internal regulatory team
    • Clinical operations teams that need experienced capacity
    • Sponsors preparing an IND, CTA, NDA or MAA

    When clients call us

    • A program is moving from pre-clinical work toward first-in-human studies
    • A submission timeline is approaching and the team needs support
    • Clinical trial oversight or documentation needs strengthening

    Scope

    • Pre-clinical study design and oversight
    • IND (Investigational New Drug) and CTA (Clinical Trial Application) preparation and submission
    • Phase I–IV clinical trial management support
    • NDA (New Drug Application) and MAA (Marketing Authorisation Application) filing support
    • Post-market surveillance support

    Typical deliverables

    • Development and submission plan
    • Submission-ready documentation and review comments
    • Clinical oversight plans and trial documentation support
    • Post-market surveillance process support

    Approach

    1. 01Plan. Align the development and regulatory strategy with program milestones.
    2. 02Prepare. Build the documentation and evidence the next milestone requires.
    3. 03Execute. Support study and submission execution alongside your team and partners.

    Boundaries

    BiggsB supports sponsors; regulatory decisions and submissions remain the sponsor's responsibility.

    Questions about Clinical & Pre-Clinical

    Can BiggsB act as an extension of our clinical team?
    Yes. Practitioners can embed with your team for a defined phase of work, such as submission preparation or trial oversight.

    Next step

    Describe your need on the contact page, email connect@biggsb.com, or book a consultation call.

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