Auditgraph is a technology-enabled services company focused on delivering innovative labeling solutions to the life sciences industry. We combine domain expertise with advanced technology to solve challenges in global regulatory affairs. Our international team of labeling professionals supports our clients from four locations in North America and two locations in Europe.
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.
- 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
ComplianceView™ is our proprietary technology platform designed to efficiently assess, report, and track critical safety differences between the Company Core Data Sheet (CCDS) and thousands of local country labels.
ComplianceView™ supports the entire process for Global Labelling Compliance Programs, including:
- Product Labeling Comparisons
- Artwork Comparisons
- Affiliate Review
- Management Reporting
- Remediation Plans
- Health Authority Label Updates
- Deviation Tracking
- CCDS Annotations and Clinical Overview Development