The Smart Way to Run Regulatory
Stop juggling tools. Start working in sync.
freya fusion brings your registrations, documents, submissions, and insights into one clean, easy-to-use space.
Built by regulatory experts with over 15+ years of expertise
Backed with advanced AI-ML technology
Used by teams across pharma, biotech & med devices
Medicinal Products
Medical Devices
ConsumerWhy freya fusion is the Ideal
Strategic Regulatory Partner?
Your work is complex enough. The system you use shouldn’t be.
With freya fusion, your regulatory team gets more than a set of tools - you get a connected way of working that’s built for how regulatory happens.
Whether you're submitting to health authorities, tracking global approvals, or managing hundreds of documents - freya fusion keeps everything in one place, always up to date, and easy to access.
Trusted by Industry Leaders
Module Spotlight
What you can do with freya fusion: all within one unified regulatory ecosystem
Always on AI-First Regulatory Updates
Stay ahead of global changes with real-time updates, regulatory Q&A, and query prediction powered by our in-house AI, Freya.
Top Features
- Backed by 15+ Years of Freyr’s Regulatory and compliance Expertise
- Access our comprehensive global database of 85,000+ regulations across 180+ markets, continuously expanding
- Real-Time Regulatory Updates with 2300+ AI-powered web bots delivering the latest Intelligence
Accelerated Regulatory Submissions with AI
Manage electronic submissions with precision and submit with confidence.
Top Features
- eCTD v4.0 Ready - we've got you covered.
- Auto-validation for regional formats (FDA, Health Canada, EMA, TGA, GCC, Japan , China & South Africa).
- QC of Hyperlinks, bookmarks and TOC automation.
- Submission logs & audit trails.
Your AI-First Regulatory Wiz
freya chatbot provides instant answers to regulatory queries.
Top Features
- Ask ‘freya’ complex regulatory questions and receive accurate, context-aware answers-so your teams reduce research time and make faster, more confident decisions.
Purpose-Built Regulatory Document Management
Stay inspection-ready and control your regulatory documents with full traceability and compliance.
Top Features
- End-to-end document lifecycle management.
- AI-powered document search & retrieval.
- Version control & 21 CFR Part 11 e-signatures.
- Integrated with RIMS, submissions, and labelling workflows.
Global Registration & Lifecycle Intelligence
Track with clarity and manage registrations, renewals, and variations across global markets.
Top Features
- Centralized product registration tracking.
- Automated renewal alerts & compliance monitoring.
- Market-wise registration status dashboards.
- Linked to regulatory content & submission history.
Regulatory Workflow Automation
Free your team from manual tasks and activate smarter workflows with freya.automate. From publishing to validation, it streamlines regulatory processes with speed and precision.
Top Features
- AI-enabled workflows for document comparison, formatting, and structured content creation
- Custom AI workflows for SME’s
- Translate regulatory content across multiple languages while preserving regional context and compliance accuracy.
- Freyr’s embedded Regulatory Intelligence
Spotlight Features
Unified Regulatory Information Management
A centralized platform connecting all regulatory data, workflows, and modules-so you eliminate duplication, improve data integrity, and stay inspection-ready.
Cloud-Native, Scalable Architecture
Easily configure data models, workflows, and UI layers-so you can adapt quickly to changing global regulatory requirements without delays or revalidation.
AI-Powered Automation & Intelligence
Built with an AI-first foundation, Freya Fusion automates routine tasks, integrates multiple LLMs, applies AI guardrails, and delivers real-time compliance insights-so you work smarter and faster.
Automated Regulatory Intelligence
Get real-time regulatory updates from global health authorities, powered by advanced AI and a conversational assistant-so you're always informed, compliant, and proactive.
Component-Based Cognitive Content Management
Leverage a structured, component-based approach to content-so you can reuse, localize, and maintain consistency across the entire submission lifecycle.
Real-Time Submission Planning & Tracking
Monitor submissions and regulatory activities with intelligent dashboards, KPIs, predictive analytics, and automation-so you ensure on-time delivery and avoid bottlenecks.
Conversational Regulatory Assistant
Ask ‘Freya’ complex regulatory questions and receive accurate, context-aware answers-so your teams reduce research time and make faster, more confident decisions.
AI-Structured, Agentic Content Authoring Workflows
Transform authoring with AI-driven, guided workflows and component-based approach that enable seamless content reuse throughout the entire submission lifecycle - so you reduce rework and accelerate approvals.
Built for Teams Like Yours
Regulatory Affairs & Operations.
Compliance & Strategy.
Submission & Publishing Teams.
QA, RA, and Document Managers.
IT & Procurement.
Get Started
Whether you’re a team of 5 or 500, Freya Fusion scales with you.
Secure. Scalable. Reliable. | Used across 50+ countries. | Designed with over a decade of regulatory experience.