Leveraging eCTD Templates at the Early Stage of Drug Development
Jul13

Leveraging eCTD Templates at the Early Stage of Drug Development

eCTD templates set the tone at the early stage of drug development for a smooth, standardized presentation of information in future regulatory submissions. Templates are favorable when compared to creating documents from scratch. Authoring templates make it easier to write summary documents and easily repurpose information from multiple reports without worrying about reformatting. High-quality documents are a precursor to successful submissions. Leveraging templates is one way to help make this possible.

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Free CTD, eCTD Templates

Our friends at iRegulatory have just posted a free set of eCTD templates. You can find the templates here. 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. Click Here for Information on GlobalSubmit’s eCTD Authoring Templates For those of you who have not...

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Updating Documents Created with Paper Templates for eCTD Submission

I recently had a great chance to talk to Virginia Ventura of FDA’s Electronic Submission Support Team about the common mistakes made by sponsors in preparing eCTDs. Virginia told me that mistakes are not confined to small or inexperienced companies. In many cases, these errors result from a lack of basic QC. Here are some examples: Not updating documents that were created based on templates intended for paper. Of course, adding...

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