fusion:
For Medicinal & Pharmaceutical Companies
Your AI-First Unified Regulatory Cloud Platform
Managing regulatory activities for medicinal and biological products-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-powered platform-purpose-built for the pharmaceutical, biotechnology, and medical device industries.
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.
Whether it's marketing authorization in the EU, variations in the US, or renewals across APAC, with each region comes its own set of rules, formats, and timeframes.
Whether it's marketing authorization in the EU, variations in the US, or renewals across APAC, with each region comes its own set of rules, formats, and timeframes.
Fragmented Regulatory Functions
Submissions, registrations, labelling, 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 Can You Do 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 helps you plan, compile, and validate submissions with support for eCTD 4.0, NeeS, and other formats. Reduce rework and speed up approvals.
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 workflow 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 helps you filter the noise and focus only on what matters to your products and regions.
Smarter labelling operations to 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.
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
Labelling & Packaging Teams
Update core and local labelling 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.