Regulatory affairs of human drugs, veterinary drugs

  • National Registration
  • Central, DCP, MRP Registration
  • Variations both Type
  • Renewal of Registration
  • Transfer of Marketing Authorisation
  • Translation of essential documents in 11 languages
  • Converting of existing dossier to a real eCTD.

    • Regulatory Affairs Services and Licensing

  • medical devices
  • food supplements
  • diagnostic substances
  • cosmetics registration

    • Clinical Trial I-IV

  • Preparing the Study Protocol and CRF
  • Project Management
  • Translation of essential documents
  • Selection of centres
  • Selection of special patients groups
  • Feasibility analyses
  • Trial approval procedure by Health authorities and EC
  • Monitoring incl. source data verification
  • Audits, quality assurance

    • Marketing

  • Drug Marketing Analyses for human, veterinary drugs and medical devices
  • Marketing Research and Consulting
  • Categorisation and Price Assessment of the products
  • Assessment of Import Price by Ministry of Finance
  • Assessment of Sale Price by General or National Health Insurance
  • Representation of Drugs (very large database of customers/doctors)
  • Pharmakovigilance of the Drugs