Leveraging eCTD Templates at the Early Stage of Drug Development

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Many writers and authors do not think what they are writing will make it into a regulatory submission, or they do not have that goal in mind. The reality is some or often all of it may. A helpful option for professionals contributing upstream to consider when preparing for the eventuality of regulatory submission is simple, easy-to-use authoring templates.

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.

Templates pre-formatted according to eCTD submission standards have built-in styles and make maneuvering from portrait to landscape orientation easy. An ideal package of eCTD templates provides users an inventory of up-to-date documents in all eCTD modules and sections. Here’s a quick checklist of what to look for in regulatory submission authoring templates:

  • Support many regions
  • Be at the correct granularity (level of detail)
  • Easy to use
  • Uniform sytle for creating Table of Contents (TOC), headers, footers and pagination
  • Consistent creation of tables, figures and references
  • Facilitate creation of internal hyperlinks with Microsoft Word
  • Generate submission-ready PDF documents with the push of a button

The use of templates at the pre-clinical and Phase 1 stages will greatly help medical writers and authors create content in a format fit for future regulatory submission. Templates will also boost productivity and minimize the work you’ll need to do as part of the eCTD submission publishing process. And most importantly, your team can focus on content rather than worrying about format.

Author: Rob Labriola

Rob Labriola has 20 years experience in regulatory operations for the pharmaceutical industry. Mr. Labriola has seen it all and truly understand the frustrations and rewards of moving to eCTD. He has worked on multiple application types (INDs, NDAs, BLAs, CTAs, NDSs, JNDAs and MAAs), and has extensive international experience, having submitted applications to the FDA, Canada, Europe, Switzerland, Australia, Israel, Japan, etc.

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