Regulatory Labeling Consulting for Pharma

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