eCTDBuilder^® provides a one-stop solution for eSubmission. Building the XML backbone that constitutes the electronic CTD, without the need for the user to understand XML and eCTD Document Type Definition (DTD). eCTDBuilder has built-in intelligence that makes the creation of electronic CTD submission seamless, reliable, and of high quality throughout the life cycle of a drug product.

Features:

• ICH DTD compliant includes support for versions 3.0 and 3.2   
• Most recent regional DTD support: FDA, EMEA, MHLW-Japan, Health Canada and Taiwan   
• Study Tagging File support (v2.0 and v2.2 and FDA SDS v1.1 support)
• Support for PIM and SPL
• Automated features to "Correct File Tag" as described in pg. 14 of FDA STF v2.2 specifications
• Reports on Submission Statistics, Cross referenced files, and Life Cycle Management Reports)
• Multi-User support
• Multi-Language support
• Autoloader - add the entire study contents in one action, along with STF tagging
• Life Cycle Management - Capability to append, replace or delete a document (no dependency on the filename)
• New ICH recommended Validation Criteria (a.k.a Q36)
• Templates for both ICH and Regional Modules with agency recommended leaf placeholders drag and drop to add CTD content
• Built-in intelligence to create Elements and Leaves according to eCTD DTD specifications.  When a file is dragged to an element the application suggests the appropriate title, file name and folder name, according to agency specification/recommendations
• Built-in support for PDF optimization for fast web delivery
• Cloning support - capability to clone submission from one region to another region
• Support for verifying and reporting password protected and security enabled documents in the submission
• Support for verifying and reporting of invalid and broken hypertext links and bookmarks
• Integrated with Documentum and QDoc electronic Document Management Systems
• Allows user to work on multiple submissions simultaneously
• Capability for user to view documents using native applications from within the application