• Variations to Licence (clinical and quality) in EU (type I and II); US (Assessment report, CBE, PAS)
  • Life Cycle Management
  • Licence Renewals, PSUR preparation
  • Pharmacovigilance
  • Line Extensions
  • New Applications
  • Due diligence
  • Pricing and Reimbursement Activities
  • Regulatory Compliance
  • Re-classification (POM to P to GSL)
  • Contract QP
  • Patent protection
  • Divestments and Discontinuations
  • Europe
  • North America
  • Asia