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