Regulatory Open Forum

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  • 1.  qualifying a CRO for nonclinical studies

    Posted 17-Oct-2023 13:32


    Is there a way to find out if a potential nonclinical CRO has had issues with regulatory compliance in the past?

    -Anononymous member

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  • 2.  RE: qualifying a CRO for nonclinical studies

    Posted 18-Oct-2023 02:01

    Some information is available publicly (the FDA and other databases), but due diligence is the best way, starting by directly asking the CRO about their inspection history. During the vendor qualification audit, they should be able to provide you a redacted copy of the 483 or other audit reports over the past several years. These will give you a good idea about their commitment to regulatory compliance.

    Harri Jarvelainen, DVM, PhD, MBA, DABT, ERT, Adj Prof


    Harri Jarvelainen

  • 3.  RE: qualifying a CRO for nonclinical studies

    Posted 18-Oct-2023 09:07

    In addition to the point make by Harri, my company published a blog on how to choose a CRO which may be of interest and provides some additional questions to consider.

    Wade Munsch
    Regulatory Affairs Manager
    Biotex, Inc.
    Houston TX
    United States
    Company Website:
    Test Lab Website: