EUROPE:

EU Authorized Agent / In-Country Care Taker

Drugs:

  • Product Life Cycle Management
  • Clinical Studies
  • Regulatory Strategy Consulting and Liaison
  • Active Substance master file / COS (Certificate of Suitability)
  • Dossier preparation and conversion of CTD to e-CTD
  • CTAs and IMPD, MAA
  • Vaccine antigen master file
  • Plasma Master File
  • Readability testing
  • Product information (labels, leaflets and SPC) writing
  • Annual Report
  • Query Management
  • Risk Management
  • Pharmacovigilance
    • PSUR
    • PV Consulting (AERS, SAERS, Case Reporting, Literature Search, etc.)
    • Medical Communication, Training, and 24/7 Call Center

Devices:

  • Product Life Cycle Management
  • Clinical Studies Consulting
  • Regulatory Strategy Consulting
  • CE marking Consulting
  • Liasioning with the notified bodies for CE marking
  • Technical Master File
  • Quality Management Systems
  • Labeling
  • Commercialization
  • Post marketing Vigilance studies and Risk Management
  • Medical Communication, Training, and 24/7 Call Center

Local presence to tackle local cultural and language differences (Language translation support)