Free CTD/eCTD Templates

 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.

Article written by

I am GlobalSubmit’s director of professional services. My area of expertise is electronic document management and regulatory submissions, specifically eCTD. I have 12 years of biopharmaceutical industry experience in the US, Europe, Israel and Japan, concentrating on content management for Regulatory Affairs & Submissions, Clinical Development, and Manufacturing, and in submission assembly and publishing. I have worked with over 50 pharmaceutical clients. Previously, I was the practice lead for the Subject Matter Experts/Business Analysts group at First Consulting Group (FCG), now part of CSC. I supervised a group of 12 SMEs/BAs. I was instrumental in the development of the FirstDoc® suite. I developed the project delivery methodology for FirstDoc® R&D, including training materials, project plans, workshop methodology and materials, and requirements and design specifications. I managed the design and development of FirstDoc® GMP and FirstDoc® Legal. Please feel free to contact me at kathleen.clark@globalsubmit.com if you are interested in talking about eCTD products or consulting services, or if you have ideas for the blog.

3 Responses

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  1. Shakul Hameed
    Shakul Hameed March 17, 2009 at 12:50 PM | |

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

  2. Shakul Hameed
    Shakul Hameed March 17, 2009 at 1:27 PM | |

    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.

  3. Andres Heuberger
    Andres Heuberger March 24, 2009 at 7:16 PM | |

    Thanks for the heads-up! We just linked to your post from http://blog.fxtrans.com/2009/03/free-ctdectd-templates.html

Please comment with your real name using good manners.

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