The eCTD summit

Free CTD/eCTD Templates

posted by mr.erhabi511 @ 11:12 PM
Monday, March 16, 2009

 Our friends at iRegulatory have just posted a free set of eCTD templates.  You can find the templates at http://www.ectd-resources.com/viewpage.php?page_id=2.  The download is a zip file of about 30 MB, and focuses mainly on M2 and M3.  The templates include a “Styles” toolbar which provides buttons to apply the various styles.  A brief Style Guide is included in the package as well.

For those of you who have not started re-designing your templates yet, this is a good way to get started without a significant investment.  Keep in mind that having eCTD-ready documents is a step that you should be taking right now to save you significant time and money in the future, even if you are years away from actual eSubmissions. 

Your first step in working with these documents should be to create a checklist of updates that you will need to make for your own internal authoring standards and practices.  Creating your own style guide is also recommended.

3 Responses to “Free CTD/eCTD Templates”

  1. Shakul Hameed says:

    Thank you for your useful template updates. The updated M2 and M3 Modules Templates helpful for our dossier content preparation.

  2. Shakul Hameed says:

    Could you update Information related to eDMF,NDA,BLA,IND for FDA and PIM, Types of ectd submissions , Tracking Table, CEP (EDQM), ASMF for Europe Submissions in your theectdsubmitt.com. If you will try to upadte these information in your site It will be more helpful eCTD submission Resource for us.

    Thanks and Regards
    M.Shakul Hameed.

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