.label:
Smarter Labelling 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, and life sciences sectors.
Real-World Use Cases
Medicinal Products
- Global-to-Local Labelling: 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.
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.
- Version Tracking & Change Audits: Maintain a complete audit trail of label changes, including rationale, stakeholder reviews, and approval status for regulatory inspection readiness.
- Multiregional Label Harmonization: Align device labelling content across US, EU, APAC, and LATAM markets while respecting format differences and localization standards.
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 relabeling costs, and improve speed-to-market with intelligent, template-driven workflows.
How freya.lable Stacks Up?
| Features | freya.label | Others |
|---|---|---|
| Template-Ready Labels | Automatically adapts labels to predefined templates required by health authorities. | Manual adjustments often needed, increasing the risk of errors. |
| Change Management | Tracks, logs, and compares label changes with detailed audit trails. | Limited visibility into label change history. |
| Real-Time Validation | Ensures compliance with HA requirements before submission with automated checks. | Post-submission validations lead to delays and rework. |
| Global Compliance | Supports regulatory standards across 120+ countries with region-specific templates. | Focused on limited markets or requires significant customization. |
| Team Collaboration | Facilitates seamless collaboration across regulatory, marketing, and manufacturing teams. | Basic collaboration tools with limited cross-functional support. |
| Integration-Ready | Works seamlessly with RIMS for unified workflow. | Limited or custom integrations that require significant setup time. |
| Version Control | Automated version tracking ensures audit readiness. | Manual tracking is prone to errors and missing updates. |
| Cost-Efficient Workflow | Reduces manual effort and operational costs through automation. | Higher costs due to manual processes and inefficiencies. |
Ready to Simplify Your Labelling Process?
Experience the power of automation, precision, and compliance with freya.label.
Take the first step today! Schedule a demo and discover how freya.label can transform your labeling workflows.
