Offerings

• Strategic Labeling Consulting / Go-to-Market Strategy • Labeling Translation • Labeling Compliance & Labeling Operations Tracking • HA Submissions • Label Comparisons • Submission Deferrals • Formatting & QC • Label Lifecycle Management • Structured Product Labeling (SPL) and Structured Product Monograph (SPM) • ePI • Clinical Labeling • Global Labeling Management (GLM)/ Core Labeling • Regional Labeling Management (RLM) • Content Deviation Management • Gap Analysis

• Artwork Process Consulting • Artwork Lifecycle Coordination • Artwork Studio Services (Creative Services, Product/Company Branding, Production Artwork, Artwork Adaptation) • Artwork Proofreading • Artwork Change Management • Artwork Management System • Global Artwork Translation • Artwork Illustrations • Technical Drawings (Cutterguides/Dielines) • Artwork Regulatory Compliance