Global Labeling Management Services

Global Labeling and Strategy

  • Global Labeling-DCDS & CDS: Company Core Position
  • Regional Labeling-(Local Product Documents) - USPI, SmPC, CDN Monograph and NPI
  • Health Authority-Pre and Post Approval Regulatory Labeling Support
  • End User-Prescriber Information and PILs

Label Development

Development of target product profiles

  • Development of target Labeling and Artworks
  • Development of Investigational Brochure
  • Design and writing of Labeling content & Mock-ups
  • Management of non-compliant proposed Labeling content

Product Information

Creation of Product Information(SmPC/PL/Label)

  • Comparative analysis of local label content - Gap Analysis
  • Labeling project management systems to manage requests, decision documentation, implementation tracking, and integration of product knowledge bases
  • Product Naming & National submissions