REGULATORY AFFAIRS

    • marketing authorisation procedure of VMPs
      • choice of the suitable way for your needs
      • preliminary work in compliance with current European legislation
      • data gap analysis/literature search
      • ERA (Environmental Risk Assessment) consultation
      • development of a strategy according to the found data on relevant endpoints
    • creation of SPC (Summary of Products Characteristics), PL (Package Leaflet) and other product literature, providing their professional translations (English, Hungarian, Slovak, Czech, Polish, Ukrainian, Russian language)
    • partner for importing VMPs from third countries, providing QP services for batch certification and releasing in EU area
    • preclinical requirements
      • data processing from antimicrobial resistance surveillance programmes
      • cooperation with the research organization in establishing the MIC (Minimal Inhibitory Concentration)
      • researching available data
    • clinical requirements
      • Dose - determination studies + Dose-confirmation studies
        • literature search, study design consultation
        • a specific study providing in collaboration with a research organization

    • electronic submission of applications

  • electronic applications form (e-AF) and electronic form of dossiers (e-Dossier)
  • making of dossiers in required format (VneeS) and technical validation of the dossier using VneeS Checker
  • our experiences (responsible authorities): Czech Republic, Slovak Republic, Hungary, Ukraine