.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 submission lifecycle. 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 and 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 to stay ahead of evolving IDMP requirements.
Audit Ready Approvals
Audit-ready approval trails are available.
Legacy Submission Migration
Easily migrate old submissions to a centralized digital repository for reuse and reference.
Spotlight Features
Cloud-Native, Zero Footprint
Securely access freya fusion from anywhere, via your browser (no installation needed), with AWS hosting.
Controlled Vocabularies & Metadata Management
Supports ICH and regional metadata, 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
Automates file naming, syncs metadata from DMS/RIM, converts Word to PDF, and manages placeholders for faster readiness.
Collaboration & Access Control
Enables secure collaboration with role-based access, reviewer tools, and SSO support across global publishing teams.
Global Submission Format Support
Supports eCTD v3.2.2 & 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 workflows 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.
Your team can focus on high-value work while freya fusion handles formatting, conversion, and compliance checks in the background.
How freya.submit Stacks Up
| Feature | freya.submit | The Rest |
|---|---|---|
| Centralized Platform | Unified AI-powered platform for end-to-end submission management | Single authoritative source for all submission content |
| Collaboration | Real-time collaboration and multi-user workflows | Co-authoring and reviewing tools |
| Submission Lifecycle Management | Covers planning, authoring, publishing & validation, and publishing with AI-driven automation | Comprehensive lifecycle management |
| IDMP Compliance | IDMP ready system for 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 | Automated compilation and validation for eCTD, NeeS |
| AI and Analytics | Advanced AI/ML for predictive insights, error reduction, and real-time analytics | Basic dashboards and reports with 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 |
