Covers the full workflow of eCTD dossier preparation, pre-validation, submission package publishing, and lifecycle management. Helps registration and submission teams complete the collaborative process from China eCTD preparation to compliant publishing.
Professional publishing tools built for China eCTD standards and user workflows.
Organize documents by module with drag-and-drop sorting, batch import, and structure reuse.
Automatically pre-check PDF files, XML backbone, and envelope information for compliance against the latest China eCTD v1.1 validation standards.
One-click generation of submission packages and checklists compliant with China eCTD specifications.
Supports replace, delete, and append update actions while retaining full-process change history.
Multi-role collaboration, version tracking, and review records ensure consistency across internal and external reviews.
Task checklist management of key milestones for more controlled and organized pre-submission checks.
From document preparation to submission — clear process, traceable status, improved team collaboration efficiency.
From structure and content to compliance — data and rules give you certainty.
Strict publishing quality control aligned with China eCTD submission specifications to reduce rework risk.
Structure, naming, hierarchy, and submission requirements fully aligned with domestic submission specifications.
Visual prompts for errors and risk items — quickly locate and fix issues.
Checklist management of key submission items to avoid omissions and improve approval rates.
Select the version that fits your needs and click to download.