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

Who It’s Built For!

Freya Fusion supports end-to-end regulatory operations across departments, connecting teams with data, workflows, and each other:
Freya Fusion

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

Freya Fusion Bot

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.

Freya Fusion empowers you to manage your regulatory universe with precision and control.

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