Freya Fusion for Medicinal & Pharmaceutical Companies
Your AI-First Regulatory Cloud
Managing regulatory activities for medicinal products-from development through post-approval-is more complex than ever. With expanding global requirements, frequent regulatory changes, and rising expectations around compliance, pharmaceutical teams need more than manual trackers and siloed tools.
Freya Fusion unifies your end-to-end regulatory operations in a single, intelligent platform-purpose-built for the medicinal and life sciences sector.
What Makes Medicinal Product Regulation 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.
What You Can Do with Freya Fusion
Manage Product & Registration Data in One Place
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.
Simplify Submission Planning & Publishing
Whether it’s an NDA, MAA, BLA, or variation, Freya helps you plan, compile, and validate submissions with support for eCTD, NeeS, and other formats. Reduce rework and speed up approvals.
Centralize Document Management
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.
Reuse Regulatory Content, Reduce Duplication
Create modular, reusable content blocks-like cover letters, product descriptions, and summaries-that can be quickly adapted across regions and submission types.
Stay On Top of Lifecycle Events
Track renewals, variations, withdrawals, and post-approval changes across all markets. Freya alerts you when action is needed, so you never miss a deadline.
Align Labeling & Artwork Across Regions
Manage label updates, safety changes, translations, and packaging artwork in sync with regulatory requirements. Freya ensures that what’s on pack is always up-to-date.
Get Smarter with Built-In Regulatory Intelligence
Monitor health authority updates from FDA, EMA, PMDA, and more. Freya’s AI helps you filter the noise and focus only on what matters to your products and regions.
Who It’s Built For!
Freya Fusion supports end-to-end regulatory operations across departments, connecting teams with data, workflows, and each other:
Regulatory Affairs & RA Operations
Plan, publish, and track submissions with built-in health authority logic.
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 50 markets.