Medicinal Products
Medical Devices
Consumer
Global Regulatory IntelligenceYour Only AI-First Tech Ally, Fluent in Regulatory: Overcome Industry Hurdles with
Your AI-First Software.
freya fusion is Freyr’s flagship AI-first regulatory platform, purpose-built to meet real-world compliance needs.
Backed 15+ years of regulatory expertise and powered by advanced AI and ML, freya fusion delivers a single, cloud-based ecosystem to manage the entire regulatory lifecycle - from product registrations and submission management to labeling, artwork, intelligence, change control, and more - AI-First with automation, real-time insights, and scalable compliance.
What freya fusion Offers?
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.
Freedom to Shift Your Focus From Transactional to Transformational.
Fewer Errors,
Faster Approvals
From global requirement tracking to dossier management and structured submissions, Freya ensures compliance without the chaos. Its AI-driven content planning and submission workflows mean fewer errors and faster approvals.
Optimize Regulatory
Operations
Freya Fusion acts as your orchestrator, streamlining business operations with automated regulatory impact assessments, artwork & label change management, and seamless translation services. Track projects effortlessly and gain real-time insights with built-in analytics.
Ask freya
Your AI-First Regulatory Wiz
With Generative AI, Freya Fusion enables smart conversations, prompt-driven dossier building, and content automation, ensuring consistency across global regulatory submissions. Need to track regulatory changes? Freya's keeps you updated with the latest policies and guidelines.
Plug & Play
Pick and choose the modules you need-whether it's policy tracking, component-based product information management, or automated labeling compliance. A unified interface means everything is accessible in one place, reducing friction and improving efficiency.
Reuse, Don't Repeat
Why start from scratch when you can reuse and adapt? Freya Fusion's structured content framework ensures compliance while reducing manual work across documents and regulatory filings.
See Who’s Already Ahead
with freya fusion.
freya fusion:
Built for Scale, Security, & Compliance.
Freya Fusion delivers a composable, modular, and intelligent platform, designed to adapt to evolving Regulatory need.
-
Technology
- Microservices Architecture: Freyr Fusion leverages a microservices-based design, allowing independent development and deployment of modules. This enables rapid innovation, high availability, and easier maintenance across the platform.
- Micro-Frontend Framework: Built with micro-frontend architecture for scalable UI development-each feature operates independently, improving flexibility, load speed, and maintainability across modules.
- Cloud-Native: Hosted on Microsoft Azure, Freyr Fusion is fully cloud-native, offering elastic scalability, global availability, and built-in disaster recovery across geographies.
- DevSecOps: Security is embedded across the development lifecycle. Through CI/CD pipelines and DevSecOps practices, the platform ensures frequent, secure, and reliable deployments.
- Agile-Ready: Designed to support Agile methodologies, Freyr Fusion enables frequent releases, iterative improvements, and faster time-to-value for regulatory teams.
- AI Native: From smart search to automated document classification and regulatory intelligence-AI is deeply integrated to drive smarter, faster decisions.
-
Security
Identity & Access Control
- AWS SSO + MFA - Centralized, secure access with multi-factor authentication.
- mTLS + IAM - Certificate-based and role-based access ensures only authorized users interact with resources.
Automated Compliance
- AWS Systems Manager & Config - Enforces policies and flags misconfigurations in real time.
- AWS Inspector & GuardDuty - Continuously scans for vulnerabilities and threats across environments.
Data Protection
- AWS KMS & Secrets Manager - Encrypts sensitive data and manages credentials securely.
- Glue Data Catalog - Classifies and catalogs data based on internal SoPs.
Unified Security Monitoring
- AWS Security Hub - Centralized view of security posture and compliance insights.
-
Regulatory
- Purpose-built Regulatory Solutions: Submission Management & Planning, Regulatory Information Management, Document Management & Archival, Structured Content Authoring, Labelling & Artwork, Regulatory Intelligence - powered by an AI-Enabled Regulatory Cloud with composable architecture (data, content, application, user interface).
- Compliance-First Security & Governance: GxP Compliance, ISO Standards Certification, End-to-End Audit Trails & Quality Gate Checks.
- Freya AI Portfolio: Proprietary Fine-Tuned LLMs trained on regulatory frameworks.
- Generative AI for Dynamic UI & Document Automation
- Regulatory Cognitive Agents: Real-time insights, memory, and reasoning capabilities.
- Freya Chatbot: Regulatory expertise with multilingual support for seamless cross-region collaboration & document translations.
- Intelligent Process Automation & Collaboration: Configurable applications, customized workflows & notifications, reporting with QuickSight, aligned cross-functional processes, and a conversational, multilingual Freya Chatbot for expert guidance and seamless cross-region collaboration.
Application Composability
Choose only the modules you need. freya fusion allows selective module access to match specific regulatory goals-whether you need a single function or the full suite.
The freya fusion Advantage.
Cost Advantage
The most competitively priced regulatory tech solution on the market.
Easy to Use
User-friendly experience tailored for regulatory tasks.
Quick to Deploy
Get up and running swiftly, not eventually.
360 Support
Expert help always within your reach.
Subject Matter Expertise
Built by regulatory professionals, for regulatory professionals.
One View
Centralized regulatory oversight.
freya fusion:
Your AI-First Regulatory Cloud
What You Get with freya fusion?
freya fusion vs. Other RIM Systems
| Capabilities | freya fusion | Other RIM Systems |
| AI-enabled Foundational Regulatory Cloud Platform |  |
 |
| Integrated Automation | |
|
| Embedded Regulatory Intelligence | |
|
| Regulatory Knowledge Management | |
|
| Structured Component-based Content Management | |
|
| Conversational User Interface | |
|
| Global Language Support & Translation | |
 |
| Integrated RIMS Modules | |
|
| Cross-functional Program Management | |
|
| Business Intelligence & Analytics | |
|
| Artwork and Labeling | Included | Often Missing |
Key Insight: Other systems may have some modules like registration, management, or submission, but they often lack critical functionalities such as artwork and labeling.
-
High
-
Limited
-
Low
