Octagon offers several technology solutions that support the production of eCTD submissions.

For complete submission management and eCTD capabilities, ViewPoint^®, Octagon’s enterprise submission process management solution addresses the full submission lifecycle. The ViewPoint eCTD Compiler leverages all of ViewPoint’s submission management capabilities to facilitate the compilation of eCTD submissions in the context of the dossier lifecycle. The eCTD Compiler is an additional module for ViewPoint that allows users to create eCTD submissions in compliance with ICH and regional specifications and guidances. It also allows companies to support traditional submission formats as well as the eCTD format. This flexibility helps smooth the transition that will occur as different health authorities begin to require the eCTD format.

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Octagon’s eCTD Suite
The eCTD Suite includes the Octagon eCTD Viewer and Octagon eCTD Validator.

Octagon’s eCTD Viewer is an easy to use, desktop application that was designed for the business user’s needs. Unprecedented search functionality enables users to search across sequences, modules, date ranges or attribute values. This capability distinguishes the Octagon eCTD Viewer as the solution of choice that spans the entire submission lifecycle.

Octagon’s eCTD Validator validates xml backbones produced by any eCTD compiler. This solution automates the tedious verification of critical folder, file and metadata information for US and EU (centralized procedure) submissions. Octagon’s eCTD Validator validates according to industry specifications and guidances and provides added value by incorporating Octagon best practices. This solution allows users to load and save configurable sets of validations, providing flexibility and efficiency across the submission lifecycle.

>> Download PDF of eCTD Suite Datasheet or Contact Octagon

ViewPoint^® eCTD Complete

ViewPoint^® eCTD Complete is a package of unique services and products that provides the four essential capabilities required to create and maintain an eCTD submission: compilation, issue management, validation and viewing.

The package includes fundamental services wrapped around breakthrough technologies including Octagon’s eCTD Viewer and eCTD Validator and ViewPoint^®, Octagon’s enterprise submission process management system. This combination of expert services and technologies provides a strong foundation for core eCTD capabilities. This scalable solution will enable your organization to rapidly implement eCTD while supporting the eCTD lifecycle through the concepts of good submission management.

If you are looking for a quick project ramp-up time, focused support and unparalleled technologies, contact us to learn more about ViewPoint^® eCTD Complete.