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Full-Process Support from Document Generation to Global Regulatory Submission

Combining proprietary eCTD software with a professional regulatory team
Ensuring every registration dossier meets international regulatory requirements in an efficient, controlled, and traceable manner.

Consult an eCTD Compliance Solution Learn More About the Service Workflow

  • Pain Point：The Core Challenges of eCTD Compliance

    Life sciences companies commonly face the following issues during eCTD submission:

    Mismatch between document structure and regulatory requirements;

    XML or PDF format validation failures;

    Inconsistent multilingual materials, easily leading to rejections;

    Chaotic version management, making it difficult to quickly update supplementary materials;

    Insufficient understanding of regulatory rules, leading to delays or risks.

    VS

    Solution：Our Solution

    By combining a professional team with proprietary software, we provide full-process, end-to-end compliance support:

    Regulatory requirement analysis;

    Document structure planning;

    Multilingual collaboration and quality control;

    Pre-submission validation and risk management.

  • 01
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    Regulatory and Market Analysis

    Clarifying applicable regulatory agencies and submission requirements.

  • 02
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    Document Structure Planning

    Developing strategies for modules, hierarchies, and version control.

  • 03
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    Document Generation and Initial Validation

    Using proprietary eCTD software to generate XML and PDF files.

  • 04
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    Multiple Rounds of Review and Compliance Validation

    Multi-dimensional checks on content, structure, formatting, language, and versions.

  • 05
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    Submission Support & Maintenance

    Handling supplementary materials and version updates to ensure full-process compliance and traceability.

  • Familiar with the regulatory requirements of the FDA, EMA, NMPA, and other authorities;
    
Experience covering registration types such as IND, NDA, ANDA, and DMF;
    
Providing end-to-end quality control across the entire process.
  • Fully self-controlled software: Not reliant on third parties and supporting long-term customization;
    
Built-in regulatory logic: Incorporates international regulatory rules to improve submission success rates;
    
Integrated service and system workflows: Ensuring language, content, and structure remain fully controllable throughout the process.

New Drug Registration eCTD Submission Project
Challenge

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

Solution

Using proprietary eCTD software to generate standardized XML and PDF files, combined with multiple rounds of validation by the compliance team.

Results

Submission passed official validation on the first attempt;
Consistent structure across multilingual materials;
Costs for subsequent supplementary materials reduced by 50%.

Generic Drug International Registration eCTD Lifecycle Management Project
Challenge

A pharmaceutical company needed to simultaneously maintain generic drug registration dossiers for multiple countries, with numerous historical supplementary documents, chaotic version management, and low update efficiency.

Solution

Established a unified eCTD lifecycle management system, modularized and renumbered historical materials, and achieved synchronized maintenance of multi-country versions through standardized XML construction and automated validation tools.

Results

Historical material management became clearer and more standardized;
Efficiency of synchronized updates for multi-country versions increased by 60%;
Effectively reduced the risks of repetitive organization and technical rejection.

Biologics Overseas Submission eCTD Technical Compliance Project
Challenge

A biopharmaceutical company was undertaking its first overseas regulatory submission and lacked experience with eCTD technical requirements, resulting in file formats and directory structures that did not meet official standards.

Solution

The eCTD compliance team provided one-stop support covering document standardization, PDF optimization, bookmark linking, and XML backbone construction, and completed multiple rounds of technical validation and mock review before submission.

Results

The eCTD files successfully passed official technical validation;
Directory structure and lifecycle management met international standards;
Helped the client shorten the overseas registration preparation cycle and improve submission efficiency.

  • If you want:Submission materials to pass validation on the first attempt;
    Document structures to remain controllable over the long term; • Multilingual materials to be consistent and traceable;
    We provide proprietary eCTD software and end-to-end professional services.

    Consult on eCTD Compliance Services Upload Documents for Evaluation
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