About freya fusion
Regulatory-born, tech-built: 15+ years of domain expertise, uniquely combined in one AI-First RIMS.
freya fusion is Freyr’s flagship AI-First regulatory platform, designed to meet complex, real-world compliance needs. Grounded in 15+ years of regulatory expertise and driven by advanced AI/ML, freya fusion is a unified ecosystem that empowers RIM and covers the entire regulatory lifecycle - from registrations and submissions to labeling, artwork, intelligence, and change control.
0
Regulations Tracked
0
Time Savings
0
Automations
0
Global Markets Covered
AI-First Regulatory Technology
freya fusion is modular by design. Enable what you need today, scale platform - wide as priorities grow.
Platform Intelligence
1. Generative AI (freya)
From AI-First draft dossiers to conversational help via freya, our domain-trained GenAI accelerates eCTD, labeling, and RTQ with fewer clicks, faster reviews.
2. Agentic AI
Meta-prompted, spreadsheet-managed “recipes” run across multiple LLMs (cloud/VPC/on-prem) to collect, validate, draft, and route—guardrailed and auditable.
3. Knowledge Manager
Tenant-specific code lists and a governed domain model create a single source of truth. Boosting retrieval quality and AI accuracy across markets.
4. Data Composability
One unified regulatory data model links registrations, submissions, labeling, and artwork. No re-keying, clear lineage, consistent reporting.
5. Micro-Services Architecture
Domain-driven, containerized services are independently deployable with deep observability—keeping RIM integrations and uptime enterprise-grade.
Built for Scale, Security, & Compliance
freya fusion delivers a composable, modular, and intelligent platform, designed to adapt to evolving regulatory needs.
Domain
Digital
Data
Deep Regulatory Expertise
- Purpose-built for RA: eCTD submissions, RIM, DMS/archival, structured content, labeling & artwork, and regulatory intelligence—designed around HA workflows.
- Proven at scale: 15+ years, 2,200+ experts; 200,000+ submissions, 2,000+ approvals across 120+ countries and 70+ categories.
AI-First Regulatory Cloud
- Agentic AI: Meta-prompted, multi-LLM workflows collect → validate → draft → route—guardrailed and auditable.
- Regulatory LLMs: Proprietary, fine-tuned models for RA tasks; deploy in public cloud, VPC, or on-prem.
- Conversational UI: Multilingual freya chatbot guides tasks, pre-populates forms, and surfaces guidance with sources.
- Security & Governance: GxP-ready, ISO-certified controls, quality gates, RBAC, and end-to-end audit trails.
Four-Dimensional Excellence
- Quality: Authenticated sources with real-time updates across 1,598+ HAs; expert curation and knowledge-tagging for optimized AI retrieval.
- Breadth: Discovery-to-post-market coverage across pharma, biologics, devices, and consumer; 200+ markets and 125+ product types.
- Depth: Historical + real-time regs and predictive signals; near 100k regulations/standards tracked.
- Authority (Data Composability): One unified regulatory data model—enter once, reuse across registrations, submissions, and labeling with governed lineage.
What freya fusion Offers
1/8
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 Intelligence
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.
The freya fusion Advantage
Quick to Deploy
Get up and running swiftly, not eventually.
360 Support
Expert help is always within your reach.
Subject Matter Expertise
Built by regulatory professionals, for regulatory professionals.
One View
Centralized regulatory oversight.
Cost Advantage
The most competitively priced regulatory tech solution.
Easy to Use
User-friendly experience tailored for regulatory tasks.
What Our Clients Say
See Who’s Already Ahead
with freya fusion
