eCTD v4.0 Ready. PMDA Compliant.
Built for What’s Next.
Future-Ready Submissions for the Japanese Market
As PMDA transitions to eCTD v4.0, regulatory teams need more than a publishing tool-they need precision, speed, and confidence. freya.submit is engineered to meet the latest submission requirements and elevate your global compliance game.
Why Choose freya.submit for eCTD v4.0?
Purpose-Built for PMDA eCTDv4.0 Standards
Fully aligned with Japan’s eCTD v4.0 requirements - for both ICH and regional specifications, including new document granularity, controlled vocabularies, keywords, contextual metadata, and lifecycle management.
AI-Assisted Publishing
Auto-structure your sequences, hyperlink documents, validate submissions, and generate compliant outputs-all in a few clicks.
Reduce Submission Errors by 20%
Freya’s validator checks and helps to identify and fix errors before the PMDA does.
Accelerate Timelines by 10%
Experience faster review cycles with smart templates, automated workflows, and integrated regulatory logic.
Seamless Upgrade from eCTD v3.2
Migrate existing sequences and metadata to v4.0 effortlessly, with zero data loss and full traceability. While eCTD v4.0 is currently used for new applications, forward compatibility will enable submissions from eCTD v3.2.2 to transition smoothly to the new standard. Currently PMDA does not support forward compatibility and yet to implement the transition from v3.2.2 to v4.0.
Designed for Japan-Based Regulatory Teams.
Whether you're submitting locally or part of a global compliance hub, freya.submit adapts to your needs with regional publishing templates, audit-ready outputs, and multilingual interface support.
How freya.submit Stands Apart?
| Feature / Capability | Traditional Submission Tools | Generic eCTD Software | freya.submit |
|---|---|---|---|
| PMDA eCTD v4.0 Support | Manual workarounds | Partial | Full native support |
| AI-Guided Sequence Compilation | Not available | Limited | Yes |
| Hyperlinking & Validation Automation | Manual | Basic scripts | Built-in |
| PMDA-Specific Templates & Compliance Rules | Generic only | Needs customization | Pre-configured |
| Localization for Japanese Regulatory Environment | No | Partial | Yes |
| Support & Training Tailored for Japan | Limited | Offshore | Regional support available |
| Inbuilt eCTD v4.0 validation tool as per PMDA validation check items | External QA needed | Partial | Real-time alerts |
| eCTD Viewer in-align with eCTD v4.0 standards | Not available | Limited | Yes |