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eCTD Publishing and Submissions

Integrated eCTD platform connecting dossier assembly, publishing, PDF preparation, validation, review, lifecycle management, and Health Authority submissions across global markets. 

 
 
 
 
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From Complex Publishing Activities toSubmission-Ready Dossiers

RegX™ eCTD Publisher connects dossiers, regional requirements, sequence lifecycles, PDF standards, technical validation, deadlines, and Health Authority acknowledgements—reducing errors, validation failures, content inconsistencies, and delays through traceable, compliant submissions. 

 

 
 
 
eCTD Submission

Everything Teams Need for End-to-End eCTD Publishing

eCTD Publishing
  • Submission assembly and publishing 
  • Regional submission support 
  • Submission package preparation 
  • Support for initial submissions, and lifecycle sequences

 

  • eCTD structure validation 
  • Regional compliance checks 
  • File naming validation 
  • Sequence and lifecycle integrity checks 
  • Identify and resolve validation issues before submission  
  • Electronic submission dispatch 
  • Gateway connectivity 
  • Submission status tracking 
  • Acknowledgement management 
  • Delivery confirmation 
  • Resubmission & audit history 
PDF Toolbox
  • PDF conversion and normalization 
  • Bookmark and hyperlink management 
  • Pagination and formatting controls 
  • PDF compliance, metadata and quality checks 
  • Submission navigation 
  • Document inspection 
  • Sequence and lifecycle comparison 
  • Hyperlink verification 
  • Submission readiness assessment 

Connected Submission Lifecycle

Prepare

Collect approved regulatory content and confirm document readiness.

Assemble

Organize documents within the applicable regional eCTD structure and sequence.

Publish

Generate the electronic submission package with the required lifecycle information.

Validate

Perform technical, structural, regional, PDF, and lifecycle compliance checks.

Review

Inspect the submission structure, content, hyperlinks, metadata, and validation findings.

Submit

Transmit the approved package through the configured Health Authority gateway.

Acknowledge

Capture acknowledgements, delivery status, responses, and submission outcomes.

Maintain

Preserve submission history and manage amendments, supplements, replacements, and future sequences.

Powered by the Unified RegX™ Platform

The eCTD Publisher connects with the broader RegX™ regulatory environment through: 

Document Hub

Workflow and automation

Validation and compliance

End-to-End Traceability

Security and access controls

Regulatory analytics

Business Value for Regulatory Teams

Faster Submission Preparation

Coordinate document preparation, dossier assembly, validation, review, and publishing within one connected workflow.

Reduced Manual Effort

Replace repetitive file handling, manual compliance checks, and disconnected publishing activities with controlled processes.

Stronger Compliance

Apply consistent publishing standards, validation rules, governance controls, and approval requirements.

Improved Submission Quality

Review content, metadata, hyperlinks, navigation, and lifecycle relationships before package release.

Complete Traceability

Maintain submission versions, validation results, approvals, dispatch records, acknowledgements, and lifecycle history.

Global Submission Readiness

Support submission processes for Health Authorities such as the FDA, EMA, Health Canada, and TGA, based on applicable regional standards and configured integrations.

Advance eCTD Publishing with RegX™

Move from disconnected publishing tools and manual checks to a connected, controlled, and traceable submission environment. 

RegX™ eCTD Publisher helps teams assemble compliant dossiers, identify technical issues earlier, improve submission quality, and maintain visibility from content preparation through Health Authority acknowledgement and lifecycle management. 

 
 
 
 
 
 
 
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