eCTD Software: Templates and Authoring Tools

eCTD templates and authoring tools can make or break an eCTD software package. Even if your company receives final draft documents that appear to be ready for submission, chances are they still require a lot of work to be made fully compliant and eCTD submission-ready.

eCTD Templates

Offered by most regulatory software providers, eCTD templates are essential for a successful conversion to regulatory compliant eCTD submissions. A good eCTD software package will include a set of granular templates that have been designed to help you prepare any regulatory document for eCTD submission. Look for templates that include:

• Document Fields set up to automatically enter recurring information (e.g., Sponsor Name, Product, Manufacturer, etc.) into submission documents
• Detailed text from FDA/ICH eCTD guidance documents and/or examples of information to include in each type of eCTD submission document
• Embedded font and paragraph styles for the successful creation of tables of contents and PDF bookmarks

eCTD Authoring Tools

eCTD authoring tools typically consist of buttons and/or toolbars that are installed directly into Microsoft Word and are an important part of any eCTD software package. They will typically accompany and work seamlessly with a template package, allowing your staff to prepare compliant eCTD submissions efficiently. While particular combinations of eCTD authoring tools are highly variable and unique to each software provider, make sure that your templates are accompanied by a robust set of tools and macros to facilitate common complex tasks such as:

• Cross-linking and hyperlinking
• Figure and table insertion with autonumbering
• One-click table of contents and lists of tables and figures
• Quick access to styles and special characters