甲骨文翻译（深圳）有限公司

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End-to-End eCTD Compliance Support
An Integrated Solution from Document Generation to Submission and Maintenance

Based on a proprietary eCTD software platform
Providing pharmaceutical and life sciences companies with eCTD publishing, validation, submission, and lifecycle management support that meets international regulatory requirements.

Consult an eCTD Compliance Solution View Software Capabilities

Pain Point：The Difficulty of eCTD Is Never Just "Formatting"

In actual projects, common eCTD risks include:

Non-compliant module structures, leading to technical rejection;

XML construction errors, resulting in validation failures;

Chaotic file versioning, making lifecycle management difficult to control;

Misalignment between document language, structure, and regulatory requirements;

Reliance on third-party software, limiting modification and expansion.

eCTD is not merely a document issue, but a systemic compliance issue.

VS

Solution：Our Solution

A Dual-Engine Approach: Proprietary eCTD Software and Professional Compliance Services

At the software level: controllable structure, validation, and lifecycle management

At the service level: deep understanding of regulations, content, and regulatory logic

eCTD Compliance Support Workflow (Linear Progress)

01

Regulatory Pathway and Regulatory Requirement Analysis

Clarifying applicable regulatory agencies and technical specifications.
02

eCTD Architecture Planning

Developing module structures, lifecycle, and submission strategies.
03

Proprietary eCTD Software Development

Generating XML and directory structures through the system.
04

Multiple Rounds of Technical and Compliance Validation

Ensuring compliance with official validation tool requirements.
05

Submission and Subsequent Maintenance Support

Supporting updates, supplements, and long-term management.

Layered QA Logic

01

Bottom layer

Regulatory and technical rules
02

Middle layer

Structure and content Consistency
03

Top layer

Pre-submission validation and risk control

The software is not an isolated tool
Seamless collaboration with compliance consulting, translation, and Localization

Upfront validation of structural rules
Reducing human error rates
Increasing the first-time pass rate

Not reliant on third-party commercial software
Supports customized functional expansion
Long-term maintenance and continuous upgrades

Deeply serving the life sciences and pharmaceutical industries
Familiar with mainstream international regulatory systems
Extensive experience in supporting long-term registration projects
Guided by core principles of compliance, stability, and traceability

Multilingual Registration Dossier eCTD Standardization and Restructuring Project

Challenge

Multilingual registration dossiers with complex historical versions, posing a risk of technical rejection.

Solution

Unifying the structure and restructuring the submission logic using proprietary eCTD software.

Results

XML validation passed on the first attempt;
Clear and maintainable submission structure;
Costs for subsequent supplementary materials significantly reduced.

Biologics Supplemental Application eCTD Lifecycle Management Project

Challenge

A biologics project required frequent supplemental submissions after approval, resulting in a large number of historical sequences, duplicate files, and chaotic lifecycle references.

Solution

Using eCTD software to organize and restructure historical sequences, automatically linking lifecycle operations such as replace, append, and delete, while centrally managing subsequent supplemental submission content.

Results

Clear and traceable lifecycle relationships;
Significantly improved efficiency for subsequent supplemental submissions;
Effectively reduced the risk of rejection caused by reference errors.

Innovative Drug International Registration eCTD Publishing Project

Challenge

An innovative drug company undertook simultaneous FDA and EMA submissions for the first time. The dossiers involved multiple languages and numerous historical versions, with a complex directory structure, posing a risk of technical rejection.

Solution

Unifying the CTD module structure using proprietary eCTD software, automatically generating the XML Backbone, and systematically validating and managing bookmarks, hyperlinks, file naming, and lifecycle relationships.

Results

XML validation passed on the first attempt;
Standardized and unified international submission structure;
Significantly improved efficiency in subsequent sequence maintenance.

eCTD Is Not Just a Submission Tool, but an Integral Part of the Regulatory Framework

If you want: Submission structures to remain controllable over the long term
Clear and explainable compliance logic
Software and services not bound by external tools
Then, proprietary eCTD software combined with end-to-end support is the more reliable choice.

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