Authoring Templates are a Good Foundation for Electronic Submissions

Authoring Templates are a powerful tool for creating the right content for your regulatory submissions. Well-formatted documents show the Regulatory Agency consistency and professionalism. Furthermore, the use of authoring templates in the CTD format makes content re-use simple and saves time because all previously written information is consistently formatted. 

Authoring Templates:

• Ensures compliance with International Conference on Harmonization (ICH) and US Food and Drug Administration (US FDA) guidance documents for the CTD format and appearance of documents intended for regulatory submissions 

• Available in a wide range of document types from IND to eCTD and specific regulatory documents

• A common starting point and consistent CTD formatting are supplied in standard best practices use of Word styles

• All templates come with macro-free, customized toolbars for standard CTD format applications

• Allows ease of creation of Tables of Contents, automatic bookmarks creation and consistent hyperlinking structures in and between documents

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