Regulatory Open Forum

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  • 1.  eCTD Viewer

    This message was posted by a user wishing to remain anonymous
    Posted 26-Jun-2017 13:01
    This message was posted by a user wishing to remain anonymous

    All,

    We are looking for eCTD Viewer software that is either free or affordable that does not have advertisements included.  Could you point me to one that you've used and are satisfied with the product?  Thanks in advance.


  • 2.  RE: eCTD Viewer

    Posted 26-Jun-2017 16:02
    ​Hi,

    Are you using a contract publisher?  You should be able to obtain viewer access from the publishing company.

    Best Regards,

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    Tyng-Yi (Tina) Lee MS RAC
    Consultant
    North Brunswick NJ
    United States of America
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  • 3.  RE: eCTD Viewer

    Posted 26-Jun-2017 18:46
    It seems like your company has outsourced regulatory submission and you would like to review it before submission.

    You may request the outsourcing company to provide eCTD files including XML on a CD or flash drive. Usually XML files open in internet explorer only with specific version.

    If still you are not able to see that XML files than contact your outsourcing company and get the recommendation what IT features you may need in order to see the XML file.




    ------------------------------
    Gaurang Bhavsar, MS
    Scientist-II, R&D and RA
    Sunrise Pharmaceutical, Inc.
    Rahway, NJ 07065
    USA
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