Regulatory Open Forum

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  • 1.  eCTD Storage and Viewer

    Posted 28-Feb-2019 13:35
    I have recently joined a small start up where we have an outside vendor compile, publish and submit our eCTD files to FDA.  Following submission they are returned to us for filing/storage.  Can anyone recommend an affordable, easy to access eCTD viewer system that we can buy off the shelf?  I have a quote from the same vendor we are using for our eTMF, but it seems high to me.  For example, to be able to have a file structure by sequence, it is an extra $xx/month - the default is strictly by module.  Appreciate any advice and direction!

    Beth Weinberg
    Regulatory Affairs Lead
    Carmel IN
    United States

  • 2.  RE: eCTD Storage and Viewer

    Posted 01-Mar-2019 08:32
    One option is to change publishing vendor to one that has a viewer as part of the service.  I have looked at viewers in the past and did not find any reasonably priced that would provide a view of an entire file (all compiled modules), but only by sequence. The service provider we use includes a viewer where I can review a sequence while it is being built and see every submission for the whole IND/NDA. And, it is not more expensive than a previous service provider who only provided the sequence after it was published.

    Glen Park PharmD
    Executive Director, Regulatory Affairs and Quality Assurance
    Jersey City NJ
    United States

  • 3.  RE: eCTD Storage and Viewer

    Posted 01-Mar-2019 09:14
     Hi Beth,

    My wife works for a publishing vendor ( where they utilize eCTD Office's eCTD Viewer (  Prior to purchasing they looked into a few solutions and found this one to be affordable and easy to use.  They offer a free trial period, which is helpful to ensure it suits your needs.  If you have any questions, please let me know; I'd be happy to connect you to her if you have any questions about her experience with the tool.


    Josh Phillips
    Regulatory Operations
    Reading PA
    United States