CTD/eCTD Support

Overview

The Common Technical Document (CTD) and electronic Common Technical Document (eCTD) provide standardized formats for presenting regulatory information to health authorities. Effective preparation requires accurate document placement, consistency across modules, lifecycle control, and compliance with market-specific submission requirements.

Mediature GxP Solutions Pvt. Ltd. (MGS) supports pharmaceutical, biopharmaceutical, and other regulated organizations with CTD/eCTD document preparation, review, compilation support, module coordination, lifecycle updates, and submission-readiness activities.

Our approach focuses on helping clients organize regulatory content clearly, identify missing or inconsistent information, and maintain structured documentation throughout the submission lifecycle.

Our CTD / eCTD Services

CTD Structure & Module Support

Support for organizing regulatory documentation within the applicable CTD structure, including module-level document mapping and completeness review.

Module 1 Support

Support for region-specific administrative and product information required by the target regulatory market.

Module 2 Review & Coordination

Review and coordination of quality, non-clinical, and clinical summary documentation, where applicable.

Module 3 Quality Documentation Support

Compilation and review support for drug substance and drug product quality documentation, manufacturing information, specifications, analytical procedures, validation data, stability information, and related technical content.

Modules 4 & 5 Coordination

Support for organization and review of non-clinical and clinical documentation, where applicable and within the agreed project scope.

eCTD Document Preparation Support

Support for organizing submission documents in accordance with the required electronic dossier structure and document conventions.

Document Readiness & Formatting Review

Review of document naming, version control, completeness, formatting, consistency, and readiness for electronic submission.

Lifecycle Update Support

Support for updates associated with variations, amendments, renewals, responses, and other post-approval regulatory activities.

Cross-Document Consistency Review

Assessment of consistency across CTD modules, product information, manufacturing details, specifications, labelling, and supporting documents.

Key Areas We Support

Depending on the submission scope, MGS can support:

• CTD document mapping
• Module organization
• Administrative documentation
• Quality summaries
• Drug substance information
• Finished product information
• Manufacturing-process documentation
• Specifications
• Analytical procedures
• Method validation
• Stability documentation
• Process-validation information
• Packaging information
• Labelling documentation
• Clinical and non-clinical document coordination
• Lifecycle documentation
• Submission-readiness review
• Cross-module consistency

Our Approach

• Understand the Submission

Review the product, target market, regulatory pathway, submission type, and applicable CTD/eCTD requirements.

• Map the Documentation

Identify available documents and map them to the appropriate dossier modules and sections.

• Identify Gaps

Highlight missing, incomplete, outdated, or inconsistent documents that may affect submission readiness.

• Compile & Review

Support organization, technical review, and consistency checking of the dossier content.

• Prepare for Electronic Submission

Support document readiness, naming conventions, version control, and lifecycle organization for eCTD publishing or submission processes.

• Maintain the Lifecycle

Support subsequent updates, amendments, variations, and other lifecycle activities.

Deliverables

Depending on scope, MGS can provide:

• CTD/eCTD document map
• Module-wise checklist
• Dossier completeness review
• Document-gap tracker
• Module compilation support
• Cross-document consistency review
• Submission-readiness checklist
• Lifecycle update tracker
• Technical review comments
• Final document-readiness support

Why Choose MGS

Structured Submission Support

Our approach helps clients organize complex regulatory information into a clear and manageable submission structure.

Quality & Regulatory Integration

MGS can evaluate CTD content from regulatory, quality, manufacturing, validation, and technical perspectives.

Consistency Focus

We help identify inconsistencies across modules before they result in regulatory questions.

Flexible Support Model

Clients can engage MGS for complete CTD/eCTD support or targeted assistance with selected modules or sections.

Lifecycle Perspective

Our support can continue beyond the initial submission to variations, amendments, renewals, and dossier maintenance.

Who We Support

MGS can provide CTD/eCTD support for:

• Pharmaceutical companies
• API manufacturers
• Finished dosage form organizations
• Biopharmaceutical companies
• Product developers
• Marketing Authorization Holders
• Contract manufacturers
• Start-ups and expanding organizations