.submit:
Accelerated Regulatory Submissions with AI.
Be the global submission architect you were meant to be with freya.submit -it’s a complete solution designed to streamline the entire initial and submission lifecycle management -so you can plan, compile, view, validate, and track global regulatory submissions with confidence, consistency, and complete control
Real-World Use Cases
Initial and Lifecycle Submissions
Easily manage variations, renewals, and post-approval changes-link to previous submissions with full traceability.
eCTD v4.0 Compliance
Stay ahead of evolving standards with built-in support for eCTD v4.0 and region-specific requirements and standards as per PMDA, FDA and EMA submissions. Soon to be available for other regions.
XEVMPD and IDMP Compliance
Manage XEVMPD submissions and IDMP readiness for submissions, stay ahead of evolving IDMP requirements.
Audit Ready Approvals
Audit-ready approval trails.
Legacy Submission Migration
Migrate old submissions to a centralized digital repository for reuse and reference.
Spotlight Features
Cloud-Native, Zero Footprint
Access securely via browser-no installation needed, with AWS hosting and remote-ready global availability.
Controlled Vocabularies & Metadata Management
Supports ICH and regional metadata, enables grouped submissions, and syncs with authority-maintained CV lists for compliance.
Submission Compilation
Drag and drop documents into structured workflows with auto-validation, metadata checks, and a built-in eCTD viewer.
Built-In Validation Rules
Authority-specific rulesets for FDA, EMA, and PMDA ensure real-time error detection during submission prep.
Automation for Submission Efficiency
Automate file naming, sync metadata from DMS/RIM, convert Word to PDF, and manage placeholders for faster readiness.
Collaboration & Access Control
Enable secure collaboration with role-based access, reviewer tools, and SSO support across global publishing teams.
Global Submission Format Support
Support for eCTD v3.2.2 and v4.0, NeeS, and paper submissions-aligned with FDA, EMA, PMDA timelines and formats.
Built-In Editing & Bookmarking Tools
Edit PDFs, create bookmarks, and add hyperlinks within the platform to ensure documents are submission-ready.
Submission Lifecycle Management
Track end-to-end submission status-from preparation to publishing-with controls to lock and preserve submission integrity.
Scalable & Customizable Workflows
Adapts to large pharma and biotech needs with configurable processes for specific product types or markets.
IDMP Compliance Built In
Supports SPOR and PLM integration to manage IDMP submissions seamlessly across regions.
Why freya.submit is the Ideal Partner for Your Submissions?
Automate repetitive publishing tasks, validate submissions in real-time, and cut down manual errors for faster turnaround.
Simplify your regulatory workflow with built-in tools designed for precision, control, and speed.
Gain full visibility into submission progress, track deadlines, and make informed decisions with real-time metrics.
Focus your team on high-value work while Freya handles formatting, conversion, and compliance checks in the background.
How freya.submit Stacks Up?
| Features | freya.submit | The Rest |
|---|---|---|
| Centralized Platform | Unified AI-first platform for end-to-end submission management. | Disjointed systems that don't scale or connect with each other. |
| Collaboration | Real-time collaboration and multi-user workflows. | Static workflows that can’t support agile teams. |
| Submission Lifecycle Management | Covers planning, authoring, publishing, and validation, and publishing with AI-driven automation. | Fragmented workflow with little traceability or version control. |
| IDMP Compliance | IDMP ready system, easy IDMP data management. | Separate IDMP system required. |
| Automation | Automated document assembly, metadata management, and validation. | Limited automation, focused more on manual oversight. |
| Publishing & Validation | Integrated eCTD viewer and validator; supports eCTD, NeeS, ACTD, and other global formats. | Most other systems have partial or no in-built validator or viewer. |
| AI and Analytics | Advanced AI/ML for predictive insights, error reduction, and real-time analytics. | Dashboards and reports; no AI-driven insights. |
| Global Coverage | Supports multiple health authorities (e.g., FDA, EMA, HC, TGA, GCC) and formats like eCTD, NeeS, and ACTD. | Focused on eCTD and NeeS formats with fewer regional options. |
