Document Templates

Generating submission-ready PDFs starts with high-quality Word documents. Companies should use a standardized set of content templates to get to this end. Document templates establish the look and feel of your dossier, but more importantly they promote compliance with granularity regulations, navigational aids (bookmarks and hyperlinks), proper formatting, and author usability.

Consistent use of Word styles and accurate cross-referencing are essential for creating submission-ready documents. Templates will ensure authors generate documents that are technically sound for publishing by setting proper margins, fonts, and enforcing best practices.

Organizations now transitioning to eCTD submissions should invest in templates – even if they’re not quite ready to submit electronically – as the documents created today will appear in an eCTD tomorrow. This proactive approach will pay off down the road when these documents are filed with the Agency.

Consider these best practices when putting document templates in place:

Build or Buy – If you don’t already have templates mapping CTD/eCTD granularity and abiding by formatting requirements, consider buying a set of templates rather than creating your own. There are several packages available at different price points and levels of sophistication. GlobalSubmit now offers templates to help content authors prepare submission-ready documents.

Control and Manage Templates – After you’ve obtained or created templates, make certain that they’re available to authors in a standard location, preferably your EDMS. Control all changes to templates by enforcing a review and approval process.

Train Authors – Authors should recognize the importance of and participate in a training program. Once the importance of document preparation to a submission is understood, authors will be less likely to modify documents in a noncompliant manner. Proper training reduces the amount of re-work performed by regulatory operations and outsourced publishing partners.