The eCTD is defined as an interface for industry to agency transfer of regulatory information, while at the same time taking into consideration the facilitation of the creation, review, lifecycle management, and archival of the electronic submission. Making a valid eCTD submission without a tool is time consuming and error prone. These potential delays and errors can cost companies millions and limit their competitive advantage. Our eCTDcomposer insures that competitive edge, helping our users make fast and accurate eCTD submissions according to the federally mandated guidelines.

Features

• Automatic creation of eCTD granularity.
• Automatic generation of XML backbone, including index.xml, regional.xml and Study Tagging File in XML format.
• MD5 checksum automatically updated accordingly.
• Create eCTD submission starting point from scratch or existing submissions such as eIND, eNDA, eBLA, or eCTD/CTD.
• User-Friendly Interface to create Study Tagging Files.
• Lifecycle Management helps user track the lifecycle of frequently-changed content.
• Built-in validation tool for checking DTD, checksum, structure, and more.
• Drag & Drop makes file/directory copy easier.
• Menu item/Toolbar buttons are automatically enabled/disabled.
• The file content can be viewed so that users can easily find the correct files.
• Many Built-In tools for creating and checking links and manipulating leaf file content and names.