Product and Educational Services LLC ("PES")

Located in the PA Biotechnology Center, Doylestown, PA 18902

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Quality Audits
 

 

Conduct quality audits including audits of clinical trial operations for compliance with:  

    • FDA 21 CFR 11
    • FDA 21 CFR 50

    • FDA 21 CFR 54

    • FDA 21 CFR 56

    • FDA 21 CFR 312

    • FDA 21 CFR 314

    • ICH E6 Good Clinical Practice

    • ICH E2A Clinical Safety Data Management

    • ICH E8 General Considerations for Clinical Trials