ViewPoint eCTD Compiler

The ViewPoint eCTD Compiler, built on the principles of the holistic submission process, connects your compilation step to upstream processes. Combined with ViewPoint’s content, task, and issue management functionality, submission teams are provided a complete tool set for producing eCTD submissions that has years of proven reliability. The ViewPoint eCTD Compiler is based on Octagon’s best practices and the latest ICH and Regional guidances.

• Intelligent lifecycle management facilitates the correct organization of your submission
• Secured environment provides a controlled repository for submissions
• Rapidly create backbones without the need to understand XML
• Integration with enterprise document management system and databases connects content to the compiler
• Integration with upstream processes connects your planning, content management and publishing tools to your compiler
• Flexible output folder structure supports importing/exporting of submissions
• Pre-compilation validation catches compliance issues sooner
• Search on leaf, document, task and issue data across dossiers
• Pre-defined and reusable content plans accelerate submission initiation
• Portfolio management approach supports reuse of components across regions