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  • 1.  MS Word templates for Common Technical Document (CTD)

    This message was posted by a user wishing to remain anonymous
    Posted 07-Aug-2020 14:00
    This message was posted by a user wishing to remain anonymous

    I'm seeking information on vendors and approx. costing for MS Word templates for Common Technical Document (CTD) for drug / small molecule /pharmaceutical  products to support Pre-IND and IND submissions. 

    We are a small company with less than 10 people - and likely only 1-3 of these people would be authors. 

    I've heard of IQVIA and Accenture providing MS Word templates.

    1. Any recommendations for firms that sell MS Word templates for INDs?
    2. Any idea of how much this will cost?

    Thank you in advance.


  • 2.  RE: MS Word templates for Common Technical Document (CTD)

    Posted 07-Aug-2020 14:14
    Even Veeva provides templates.

    ---------------------------------
    Hardik Panchal
    NJ United States
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    Original Message


  • 3.  RE: MS Word templates for Common Technical Document (CTD)

    Posted 08-Aug-2020 02:01
    Hi, 

    I'm Prathap from Accenture Solutions Pvt Ltd, yes we do provide MS word CTD word templates. Let me know if you need any further details I can help as we're the team doing that. 

    Regards, 
    Prathap

    ------------------------------
    Prathap Vedhavyasamurthy
    Regulatory Opertions - Business Process Delivery Team Leader
    Bengaluru
    India
    ------------------------------

    Original Message


  • 4.  RE: MS Word templates for Common Technical Document (CTD)

    Posted 08-Aug-2020 08:21
    Edited by Tracy Janus 08-Aug-2020 08:35
    Hi there!
    There are several good regulatory writing companies that can help you create templates that are fit for purpose.
    I think if you did a search for "regulatory writing" or "submission writing" you would have good luck finding some.  It is probably difficult without at least an initial phone conversation to come up with a good estimate, unless they are very generic, which may not really be all that useful to you in the long run.
    Good luck!

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    Tracy Janus
    VP Regulatory CMC
    Green Lane PA
    United States
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    Original Message


  • 5.  RE: MS Word templates for Common Technical Document (CTD)

    Posted 09-Aug-2020 13:12
    Go to: http://www.sagesubmissions.com/   You can download free templates on the right side of the screen.  Call 619-787-1514, if you encounter problems or want to pursue the purchase of more of these eCTD templates.  The owner has assisted many small companies with their eCTD submission needs. I am not the owner and am retired from the eCTD community. I have no commercial or financial interests in this referral.

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    S. Albert Edwards FRAPS
    President, eSubmissions University
    Lincolnshire IL
    United States
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    Original Message


  • 6.  RE: MS Word templates for Common Technical Document (CTD)

    Posted 09-Aug-2020 15:28
    There are several groups that will sell you templates. They can be useful if you do not have a Word semi-expert supporting the writing of the various sections. However, if you don't have that support, the purchased templates can be useful for helping with the formatting of the documents and will have hidden text with content guidance. However, the layout of the templates themselves are easy to prepare and follow the various CTD content guidances (including the hidden text). I have prepared my own templates for a few CTDs and they work just fine. If you choose to purchase templates, be prepared to be shocked by the price - at least last time I checked.

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


  • 7.  RE: MS Word templates for Common Technical Document (CTD)

    Posted 09-Aug-2020 20:26
    I'd just like to mention that having the eCTD templates is not enough. You will need the software to place the resulting pdfs in the eCTD backbone and create the XML files for submission. There are several companies that offer such software, but it is pricey. As a result, small firms often go to companies that have eCTD software for final publishing and submission.

    Bob Seevers
    Pearl Pathways

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    Robert Seevers
    Senior Regulatory Advisor
    Indianapolis IN
    United States
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    Original Message


  • 8.  RE: MS Word templates for Common Technical Document (CTD)

    This message was posted by a user wishing to remain anonymous
    Posted 10-Aug-2020 09:16
    This message was posted by a user wishing to remain anonymous

    Veeva Vault is rather expensive, and might not fit a small company needs.
    You might still wish to reach out to Accenture; I believe they can do by-user basis, which might reduce costs.
    Stay away from Extedo-in short you get what you pay for [terrible templates; glitchy as all get out and a nightmare when at the publishing step].
    I've used the Transcelerate templates- they aren't amazing, but are okay.

    Good luck!
    Original Message


  • 9.  RE: MS Word templates for Common Technical Document (CTD)

    Posted 10-Aug-2020 12:22
    Hi,

    Thanks for good feedback on Accenture, addition to CTD format templates we also have in house tool for eCTD publishing and submissions.

    Regards, 
    Prathap
    Business Process Delivery Team Lead 
    Accenture Solutions Pvt Ltd

    ------------------------------
    Prathap Vedhavyasamurthy
    Regulatory Opertions - Business Process Delivery Team Leader
    Bengaluru
    India
    ------------------------------

    Original Message


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