Global Labeling
Pharmaceuticals - Horsham, Pennsylvania, United States
Global Labeling Employees
Global Labeling Senior Management
Global Labeling Details
Auditgraph is a technology-enabled services company focused on delivering innovative regulatory affairs solutions to the life sciences industry. We combine domain expertise with advanced technology to solve challenges in global regulatory affairs. Auditgraph's flagship product, ComplianceView™, provides the tools necessary to assess and triage critical safety gaps between the Company Core Data Sheet (CCDS) and thousands of local country labels. ComplianceView™ manages the entire process for Global Labelling Compliance Programs, including: • Local Label Translations • Product Labeling Comparisons • Artwork Assessments • Affiliate Review • Management Reporting • Remediation Strategies • Deviation Tracking • End-to-End Labelling ComplianceView™ enables clients to view labeling deviations in a new way, thereby meeting internal needs and Health Authority requirements in a more timely, efficient and sustainable manner. Visit www.auditgraph.com to learn about our experience in global regulatory labelling. We also provide comprehensive Regulatory Affairs services. This includes product labeling, strategy and operations expertise such as: • Authoring Company Core Data Sheets • Authoring local labels (i.e. USPI, SPC) • Document Management System Data Migrations Our eCTD flagship product contains the eCTD, CTD, NeeS, paper and electronic submission filing requirements for over 160 countries. With our partners, we provide: • eCTD Publishing Support • DMS Implementation • Regulatory Strategy • Medical and Regulatory Writing • Staff Augmentation • Business Analytics Auditgraph is recognized by the industry for our visionary thought leadership in Regulatory Information Management. Our team has a passion to improve Global Patient Safety by developing and implementing client-focused solutions to meet complex global regulatory affairs challenges. Visit www.auditgraph.com to learn more about our regulatory and compliance expertise.
