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MHRA CTA without a QP Audit/declaration?

  • 1.  MHRA CTA without a QP Audit/declaration?

    This message was posted by a user wishing to remain anonymous
    Posted 15-Jan-2020 13:06
    This message was posted by a user wishing to remain anonymous

    We got some advice for a Phase 1 CTA (to MHRA) that we can submit with the QP Declaration/Audit pending. I have never done this, does anyone have experience or insights on this strategy? Specifically, how long can it remain pending? Would it pass validation? Would a signed QP statement that the audit is scheduled help chances of success?

    Thank you in advance for sharing your insights.