The electronic Common Technical Document (eCTD) is the standard format for submitting regulatory applications to health authorities including the USFDA, EMA, Health Canada, TGA, and many others. eCTD submissions require specialist technical knowledge of the XML backbone, document management, and health authority-specific publishing requirements. RBridge Lifesciences provides complete eCTD building and compilation services.
What We Offer
- eCTD Backbone Building and XML Validation
- Document Compilation and Hyperlinking
- Submission Validation (NeeS, eCTD format checks)
- eCTD Lifecycle Management (amendments, renewals, variations)
- Health Authority-specific eCTD Technical Requirements
- Publishing for USFDA, EMA, Health Canada, TGA, and others
Why eCTD Matters
- Mandatory for USFDA NDA, ANDA, BLA, and IND submissions since 2017/2018
- EMA requires eCTD for all new applications via the centralised procedure
- eCTD enables efficient lifecycle management — each sequence builds on the last
- Improves reviewer efficiency and reduces query rates when well-structured
- Requires specialist publishing software and technical validation expertise