What Make Us Who We Are?
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.
What Makes Your Work Meaningful?
More than a workplace, Freya Fusion is a community where curiosity is valued, bold thinking is celebrated, and your growth fuels our mission.
Anywhere, Anytime
Work flexibly across global time zones with remote-first policies that prioritize results over location.