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  • 1.  eCTD Software Submission Software Packages

    Posted 11-Oct-2023 16:37

    Dear RAPS members,

    My company plans to purchase an eCTD software for global submissions. So, I am polling users on the best 3 packages. The pol will close by Sunday, October 22. Thanks for your assistance with this matter.



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    [Robert] [Falcone] PhD, FTOPRA, FRAPS
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  • 2.  RE: eCTD Software Submission Software Packages

    Posted 12-Oct-2023 06:54

    Good morning,

    I have so far only worked with Starting Point from Accenture, but I do like it. I find it user-friendly and with few quirks.



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    Arvilla Trag RAC
    Principal Consultant
    CMC Compliance Services
    Iron River MI
    United States
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    Original Message


  • 3.  RE: eCTD Software Submission Software Packages

    Posted 12-Oct-2023 09:02

    Thanks for sharing 



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    [Robert] [Falcone] PhD, FTOPRA, FRAPS
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    Original Message


  • 4.  RE: eCTD Software Submission Software Packages

    Posted 12-Oct-2023 09:34

    I have worked with PharmaReady software. The software is user friendly and the support team is very helpful. Their pricing is decent too.

    https://www.pharmaready.com/



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    Mehul Govani RAC
    Regulatory Affairs Manager
    Westbury NY
    United States
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    Original Message


  • 5.  RE: eCTD Software Submission Software Packages

    Posted 12-Oct-2023 11:48
    Thanks for the feedback

    Sent from my iPhone


    Original Message


  • 6.  RE: eCTD Software Submission Software Packages

    Posted 13-Oct-2023 01:05

    I've used Lorenz DocuBridge, Extedo and eCTD office.  Of these my favourite was Docubridge, but that may have just been the one I spent the most time with.  eCTD Office was the hardest to use but had a much lower cost

    Which one works best for you may depend on what other document management and RIMS software is being used.



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    Rob Parbery
    Sydney NSW
    Australia
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    Original Message


  • 7.  RE: eCTD Software Submission Software Packages

    Posted 13-Oct-2023 03:25

    I have used Liquent insight publisher and Extedo eCTD Manager. I found the Liquent more "tidied up", which might be a benefit if you need to handle really a lot of dossiers. 

    However, the Extedo I find is more convenvient in handling, so I am quicker in managing the few dossiers I currently have and their support and their training offers are excellent.



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    Verena Kamleithner
    Regulatory Affairs Manager
    Neufeld an der Leitha
    Austria
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    Original Message


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