Regulatory Open Forum

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  • 1.  Loading through the ESG Portal

    Posted 21-Nov-2012 10:58
    We are looking for a provider to help load one document though the ESG portal, the one document being the self-registration form required under GDUFA. This initial piece of work may evolve into e-IND submissions through the portal in the future.
    We know the work is not that difficult (nothing is if you know what you are doing), but there is a pending Dec 03 deadline and we need help, preferably through a small but reliable provider.

    Please contact me at heimo.scheer@celerion.com

    Thank you

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    Heimo Scheer PhD
    Vice President, Regulatory Affairs
    Celerion
    Somerville MA
    United States
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  • 2.  RE:Loading through the ESG Portal

    Posted 26-Nov-2012 10:18
    Dr Scheer,

    If you are simply looking for services to create and/or submit SPL-format submissions (such as establishment registrations), I recommend that you check out Reed Tech (http://www.reedtech.com).  They are specialists in SPL-format submissions.

    If you're looking for more comprehensive electronic submissions services, including the compilation, publishing, and submission of eCTD INDs via the ESG, I welcome you to contact me directly so that I may discuss with you how Cato Research can meet your needs.

    Thanks,

    Evan
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    Evan Richardson RAC
    Associate Director, Regulatory Operations
    Cato Research Ltd.
    Durham NC
    United States
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