fusion:
Our AI-First Regulatory Information Management (RIM) Platform
Accelerate Regulatory Compliance. Drive Global Submissions. Manage Registrations, Labeling, and Intelligence - All in One Cloud-Based Platform.
freya fusion is an AI-First, GxP compliant and cloud native foundational RIM software that helps pharmaceutical, biotechnology, medical device, and consumer health companies manage their entire regulatory lifecycle - from global product registration to eCTD v4.0 submission management, labeling & artwork compliance, and real-time regulatory intelligence.
Discover What freya fusion Can Do
freya fusion is a next-generation Regulatory Information Management System (RIMS) designed to drive operational excellence for regulatory affairs teams. Built by regulatory and technology experts, it brings advanced AI, automation, and modular architecture to the core of your regulatory operations.
It enables organizations to:
- Manage global product registrations and lifecycle tracking.
- Automate submission publishing and ensure compliance with eCTD standards.
- Manage and author regulatory documents centrally, with in-built ability for structured content authoring.
- Control global labeling and artwork operations with easily configurable processes.
- Gain real-time regulatory intelligence from global health authorities.
- Automate regulatory workflows and reduce manual tasks.
- Provide conversational access to regulatory data through AI-powered freya Chatbot.
- Integrated business intelligence OOTB in the system.
Meet the Modules
Designed for: Pharmaceutical, Biotech, Medical Device, and Consumer Health companies.
Real-Time Global Regulatory Intelligence, Always-On
Stay ahead with AI-driven insights from over 100,000 regulations across 150+ countries. Instantly track changes, guidance, and compliance risks.
Accelerated, Automated Regulatory Submissions
Simplify sequence assembly, validation, and publishing across global jurisdictions - with full support for eCTD 3.x and 4.0.
Global Registration & Lifecycle Mastery
Seamlessly track product registrations, manage lifecycle milestones, and gain complete global oversight.
Modular Content Authoring for Regulatory Precision
Leverage a component-based content model to streamline authoring, maximize reuse, and speed up dossier creation for global submissions.
Built for Regulatory Document Excellence
Control versions, track changes, and maintain audit-readiness with a system purpose-built for regulatory document management.
Smarter, Faster Regulatory Query Resolution with AI
Handle regulatory authority queries with intelligence and agility. Precision and timeliness are no longer negotiable - they’re built in.
Workflow Automation for Regulatory Operations
Eliminate manual steps by automating publishing, tracking, validation, and reporting processes - boosting both accuracy and speed.
Your AI-First Regulatory Wiz
Ask freya anything - get fast, context-aware answers powered by your organization’s regulatory data and global intelligence.
Smarter Labeling. Built for Compliance.
Manage label content with structured templates, built-in validation, version control, and full audit trails-across all markets and SKUs.
Why Choose freya fusion
Unified RIM Software Platform
One cloud-based system for registrations, submissions, labeling, content, and intelligence.
AI-First Automation
Save time, reduce risk, and improve regulatory decision-making.
Global Regulatory Intelligence
Stay proactive and compliant with the latest regulatory updates.
Modular & Scalable
Use the modules you need today, expand as your needs evolve.
Purpose-Built for Life Sciences
Designed for pharma, biotech, medical devices, and consumer health companies.
Why Leading
Teams Choose
freya fusion?
Experience freya fusion -
The AI-First Regulatory Cloud
Reimagine how your regulatory teams manage compliance, accelerate submissions, and stay globally aligned.