Regulatory Open Forum

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  • 1.  ESG/eCTD

    Posted 30-Aug-2018 10:43
    When you create a production account and get an ESG certificate, only the person authorized to use the ESG (i.e. who is registered under the production account) can make submissions to the FDA.

    If you have several publishers in your organization, should each create a production account? If not, then how can other publishers submit through one single ESG account?

    Thanks!

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    Saurabh Kothari MSRA, MSBE, RPh, CCRP, RAC
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  • 2.  RE: ESG/eCTD

    Posted 30-Aug-2018 11:40
    ESG accounts are specific to digital certificates.
    In order to access and submit, publishers can request ESG depratment for additional accounts.
    (Company can have multiple webtrader accounts under different users)

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    Amit Jain
    United States
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    Original Message


  • 3.  RE: ESG/eCTD

    Posted 30-Aug-2018 14:14
    Thank you Amit!

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    Saurabh Kothari MSRA, MSBE, RPh, CCRP, RAC
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    Original Message


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