e-Med eCTD Publisher

China eCTD Submission Publishing & Delivery Platform

e-Med eCTD PublisherPublishing software designed for China eCTD submissions

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.

Dossier Preparation Add submission PDF files based on the latest China eCTD v1.1 templates.
Pre-Submission Validation Pre-check PDF files, XML backbone structure, and envelope information for compliance against the latest China eCTD v1.1 validation standards.
Lifecycle Management Supports sequence management and version tracking for replace, delete, and append operations.
Submission Package Generation One-click publishing to output submission document packages compliant with China eCTD specifications.
e-Med eCTD Publisher interface

Core Features

Professional publishing tools built for China eCTD standards and user workflows.

Smart TOC & Module Management

Organize documents by module with drag-and-drop sorting, batch import, and structure reuse.

Pre-Publishing Compliance Check

Automatically pre-check PDF files, XML backbone, and envelope information for compliance against the latest China eCTD v1.1 validation standards.

Auto Submission Package Generation

One-click generation of submission packages and checklists compliant with China eCTD specifications.

Lifecycle Sequencing

Supports replace, delete, and append update actions while retaining full-process change history.

Collaboration & Review

Multi-role collaboration, version tracking, and review records ensure consistency across internal and external reviews.

Visual Submission Checklist

Task checklist management of key milestones for more controlled and organized pre-submission checks.

Workflow

From document preparation to submission — clear process, traceable status, improved team collaboration efficiency.

STEP 01 Dossier preparation
STEP 02 Compliance pre-check
STEP 03 Publishing
STEP 04 Submission validation (recommended CDE official validator
Be confident before submission

From structure and content to compliance — data and rules give you certainty.

  • Contact us anytime for technical support during usage
  • For comprehensive submission support, we offer full-process consulting services
  • Worry-free comprehensive outsourcing services — our professional team delivers efficiently

Compliance & Quality

Strict publishing quality control aligned with China eCTD submission specifications to reduce rework risk.

China eCTD Specification Alignment

Structure, naming, hierarchy, and submission requirements fully aligned with domestic submission specifications.

Complete Error Prompting System

Visual prompts for errors and risk items — quickly locate and fix issues.

Pre-Submission Checklist

Checklist management of key submission items to avoid omissions and improve approval rates.

Free Download

Select the version that fits your needs and click to download.

The software is free to use — feel confident testing it in your internal projects.

Windows Version

For Windows 10/11

Download Windows

File size: 128.9 MB

Mac Version

For macOS 12+ (Intel/Apple Silicon)

Download Mac

File size: 156.3 MB