About Us
Global product labeling and compliance is our focus. We provide technology solutions and expertise for managing the lifecycle for Company Core Data Sheets and Local Labels for prescription drugs, generic drugs, medical devices, consumer products and patient information.
ComplianceVew™ is our technology designed to assess, track and report on critical safety concept gaps between the Company Core Data Sheet (CCDS) and thousands of local country labels.
ComplianceView™ supports the entire process for Global Labeling Compliance Programs, including:
- Product Labeling Comparisons
- Artwork Comparisons
- Affiliate Review
- Management Reporting
- Remediation Plans
- Health Authority Label Updates
- Deviation Tracking
- CCDS Annotations
Services
Product labeling is our focus. We provide expertise for managing all aspects of the lifecycle for Company Core Data Sheets and Local Labels for prescription drugs, generic drugs, medical devices, consumer products, and related patient information.
This includes:
- Global End-to-End Labeling Advisory Services
- Company Core Data Sheet and Local Label Audits
- Compliance Reporting for Global Label Alignment
- Pharmacovigilance Labeling Audits
- Local Label Translations
- Labeling Operations
- Current and Future State Process Assessments
- Project and Program Management
Clients
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