Regulatory Open Forum

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  • 1.  Recommendations on eCTD Software and Publishing

    Posted 15-Jan-2015 12:21
    I am working with an organization which has an existing NDA in paper format. The organization would like to perform future submissions in eCTD format.

    The organization would like to leverage internal RA resources for compilation of submissions, but leverage a provider's ESG connection. Additionally, if the functionality exists, they would prefer an option which could also handle medical device adverse event reporting.

    I am interested to hear recommendations regarding software and/or service vendors as well as any practical tips anyone may want to share who has participated in this work previously.

    Thank you!

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    Pete Carlson RAC
    Principal Regulatory Specialist
    Ecolab Inc.
    Saint Paul MN
    United States
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  • 2.  RE: Recommendations on eCTD Software and Publishing

    Posted 16-Jan-2015 07:42
    In my past, I have used Octagon Research- now Accenture. They are based in Pennsylvania, near King of Prussia/Philadelphia area. They provide gateway services, but also eCTD-ready templates, for use by the entire organization, making creating submissions a breeze.
    I think they also provide SAE/AE reporting services, but I am not sure.  
    Good luck!

    http://www.octagonresearch.com/

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    Shannon Wehrendt MA
    Senior Labeling Coordinator
    West-Ward Pharmaceuticals
    Eatontown NJ
    United States
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