Authoring Templates

GlobalSubmit’s eCTD Authoring Templates are a springboard to eCTD readiness. These templates arrive pre-loaded with proper formatting, document granularity and best practices passed on by major health authorities including the US FDA and EMA. Internally, templates allow your organization to enforce standards and conventions. Externally, templates promote compliance with standards set forth by regional authorities.

GlobalSubmit's eCTD authoring templates are part of the document management suite

 

Built-in Advantages

  • Give content authors the ability to create documents that adhere to a single standard
  • Focus shifts from formatting to content requirements
  • Render to PDF easily, maintaining hyperlinks
  • Module 2-5 templates can be used for all eCTD and CTD templates globally
  • Module 1 templates for EU and US
  • ASEAN Region ACTD templates
  • EU CTA-IMPD templates
  • Compliance with ICH and regulatory authority guidance and specifications for document granularity, content of CTD components, and navigation aids for agency reviewers.
  • Speed document creation by reducing author training on Word features needed to create compliant, well-formatted documents

Content Guidance

Instructions are embedded within the templates providing guidance on content, and the documents render to PDF easily, maintaining hyperlinks, and producing submission-ready documents.

To see the hidden text, open a template in Microsoft Word and press the paragraph button ¶. The embedded instructions will appear as italicized red text.