Business development

In & out-licensing partnership

  • Identification of marketing partner
  • Commercial and contractual discussion
  • Project launching management
  • Regulatory support

Pharmacovigilance

  • Qualified Person for Pharmacovigilance (QPPV)
  • Periodic Reporting & submission
  • ICSR Management
  • Literature screening
  • Signal management

Regulatory

  • Strategy design
  • Dossier due diligence
  • Dossier submission
  • Marketing authorization maintenance
  • DCP & National Phase
  • Prices & Reimbursement
  • Other Regulatory Agency procedures (GMP certificate, CPP, etc)
  • Readability User Testing