fusion:
For Medicinal & Pharmaceutical Companies
Your AI-First Unified Regulatory Cloud
Managing regulatory activities for medicinal products and biologics - from development through post-approval-is more complex than ever. With evolving global regulatory frameworks, frequent regulatory changes, and rising expectations around compliance, pharmaceutical teams need more than manual trackers and siloed tools. freya fusion is a next-generation Regulatory Information Management System (RIMS) that centralizes your end-to-end regulatory operations in a single, AI-first platform-purpose-built for pharmaceutical companies.
What Makes Medicinal Product Regulations So Demanding
Multiple Regions, Constantly Evolving Guidelines
Whether you're filing a marketing authorization in the EU, submitting variations in the US, or maintaining renewals in APAC, each market brings its own set of formats, rules, and timelines.
Fragmented Regulatory Functions
Submissions, registrations, labeling, artwork, and lifecycle events are often tracked in different systems — making it hard to stay aligned and audit-ready.
Post-Approval Pressures
Managing safety updates, packaging changes, or new manufacturing sites after a product is launched requires precision, and any delay can disrupt availability.
High Compliance Risk in Document & Data Management
From SmPCs and PILs to eCTD sequences and Module 1 metadata, inconsistencies can delay approvals, trigger agency queries, or result in regulatory penalties.
Discover What’s
Possible With
freya fusion
Manage global registration & lifecycle intelligence to track products, applications, and approvals across global markets — view by strength, formulation, SKU, or region. Gain clarity on what’s registered where, and what needs updating.
Accelerate your regulatory submissions, whether it’s an NDA, MAA, BLA, or variation. freya.submit helps you plan, compile, and validate submissions with support for eCTD v4.0, NeeS, and other formats.
Purpose-built regulatory document management to organize SmPCs, PILs, modules, and attachments in a validated DMS. Built-in version control, audit trails, and metadata tagging ensure you always use the right document.
Component-based content management for regulatory submissions to create modular, reusable content blocks — like cover letters, product descriptions, and summaries — that can be quickly adapted across regions and submission types.
Automate regulatory workflows for publishing, tracking, validation, and reporting workflows to improve accuracy and efficiency.
Always-on, real-time regulatory intelligence platform to monitor health authority updates from FDA, EMA, PMDA, and more. freya’s AI-first regulatory wiz, helps you filter the noise and focus only on what matters for your products and regions.
Smarter labeling operations to manage label updates, safety changes, translations, and packaging artwork in sync with regulatory requirements. freya.label ensures that what’s on pack is always up-to-date.
Who Is freya fusion Built For
freya fusion supports end-to-end regulatory operations across departments, connecting teams with data, workflows, and each other:
Regulatory Affairs & Regulatory Operations
Plan, publish, and track submissions with built-in health authority logic for faster, compliant filings.
CMC & Quality
Manage manufacturing site changes and ensure linked updates across regions.
Labeling & Packaging Teams
Update core and local labeling content, translate faster, and control packaging timelines.
Medical & Scientific Affairs
Access approved content and monitor label updates aligned with clinical safety.
IT & Compliance
Ensure secure, validated environments with audit trails and user controls.
Regional & Local Affiliates
Get visibility into product status, upcoming changes, and responsibilities.
Why Medicinal Product & Biologics Teams Choose freya fusion
Reduce time spent on manual tracking and coordination.
Gain real-time visibility into product and submission status.
Improve collaboration across global and local teams.
Stay inspection-ready with structured, compliant content.
Scale regulatory operations as your portfolio grows.
From Molecule to Market - With Confidence
Whether you're preparing your first IND, navigating a BLA renewal, or managing post-approval variations across multiple markets — freya fusion empowers you to manage your regulatory universe with precision and control.