Embedded Files
Labeling Services
Labeling Services
End‑to‑end Product Labeling development
Target Product Profiles (TPP)
Company Core Data Sheets (CCDS/CDS) and Company Core Patient Prescribing information (CCPPI)
US Prescribing Information (USPI) and US Patient Prescribing Information (USPPI)
EU Summary of Product Characteristics (SmPCs) and Patient Information Leaflets (PILs - Centralized, MRP, National)
Labeling Oversight & Strategy
Lead cross‑functional and therapeutic area groups for label development and review
Develop/review Medication Guides, Instructions for Use
Provide labeling insight and strategy to teams to arrive at consensus
Labeling review and compliance
Health Authority interactions and negotiations
Support Regulatory Agencies requiring labeling information
Legacy product support for all countries
End to End Labeling system implementation and rollout
Training and Capability development
Page updated
Google Sites
Report abuse