freya.label
Regulatory Content Without the Chaos
freya.label: Smarter Labeling Operations
freya.label is your strategic partner in navigating the intricate landscape of regulatory labeling. Purpose-built to streamline the entire labeling lifecycle, this advanced solution delivers precision, efficiency, and full compliance. From adapting new labels to managing updates, freya.label provides unparalleled control tailored for the pharmaceutical, biotech, consumer and medical device sectors.
Real-World Use Cases
01 / 02
Medicinal Products
- Global-to-Local Labeling
Cascade CCDS changes to local labels with region-specific variations and translation tracking. - Label Impact Assessment
Identify impacted markets and products instantly when core label changes occur. - Regulatory Alignment
Ensure labels meet market-specific regulatory guidelines with audit trails.
- Global-to-Local Labeling
02 / 02
Medical Devices
- UDI Label Validation
Verify Unique Device Identifier (UDI) elements across labels for consistency with regulatory databases like GUDID and EUDAMED. - Side-by-Side IFU & Label Comparison
Automatically compare IFUs, labels, and carton content across versions to catch discrepancies in safety instructions, symbols, and device specs. - MDR-Compliant Label Checks
Validate label elements such as CE mark placement, risk class, and manufacturer info to ensure alignment with EU MDR requirements. - Multiregional Label Harmonization
Align device labeling content across US, EU, APAC, and LATAM markets while respecting format differences and localization standards. - Version Tracking & Change Audits
Maintain a complete audit trail of label changes, including rationale, stakeholder reviews, and approval status for regulatory inspection readiness.
- UDI Label Validation
Spotlight Features
Global Compliance at Your Fingertips
Ensure label content aligns with international health authority requirements - no added complexity or rework.
Template-Ready Label Uploads
Easily import existing labels and adapt them to pre-approved templates required by regional regulators.
Intelligent Version Management
Track label revisions with full audit trails and change history for regulatory inspection readiness.
Collaboration Across Regulatory & Commercial Teams
Enable seamless review and coordination between regulatory, marketing, packaging, and manufacturing functions.
Proactive Compliance Validation
Detect potential compliance issues in real time to minimize submission risks and downstream delays.
Why Choose freya.label
Automate label creation and updates to improve consistency, accuracy, and reduce manual errors.
Stay compliant with global regulatory changes using a system designed to evolve with regional labeling requirements.
Built for regulatory professionals - ensuring an intuitive, efficient, and audit-ready user experience.
Save time, reduce re-labeling costs, and improve speed-to-market with intelligent, template-driven workflows.
How freya.label Stacks Up
| Feature |  | Others |
|---|---|---|
| Template-Ready Labels | Yes | No |
| Change Management | In-depth | Limited |
| Real-Time Validation | Yes | Post-Submission |
| Global Compliance | Yes | Limited |
| Integration-Ready | Yes | Limited |
| Automated Version Control | Yes | No |
| Workflow Automation | Yes | No |
