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

  • 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. 

  • 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 labeling 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 re-labeling costs, and improve speed-to-market with intelligent, template-driven workflows.

Ready to Simplify Your Labeling Process?

Experience the power of automation, precision, and compliance with freya.label. Take the first step today!

How freya.label Stacks Up

Feature

  • Template-Ready Labels
  • Change Management
  • Real-Time Validation
  • Global Compliance
  • Team Collaboration
  • Integration-Ready
  • Version Control
  • Cost-Efficient Workflow

  • Automatically adapts labels to predefined templates required by health authorities
  • BuiTracks, logs, and compares label changes with detailed audit trailslt-in
  • Ensures compliance with HA requirements before submission with automated checks
  • Supports regulatory standards across 120+ countries with region-specific templates
  • Facilitates seamless collaboration across regulatory, marketing, and manufacturing teams
  • Works seamlessly with RIMS for unified workflow
  • Automated version tracking ensures audit readiness
  • Reduces manual effort and operational costs through automation

Others

  • Manual adjustments often needed, increasing the risk of errors
  • Limited visibility into label change history
  • Post-submission validations lead to delays and rework
  • Focused on limited markets or requires significant customization
  • Basic collaboration tools with limited cross-functional support
  • Limited or custom integrations that require significant setup time
  • Manual tracking is prone to errors and missing updates
  • Higher costs due to manual processes and inefficiencies