PHARMACOVIGILANCE

Our goal is to increase the efficiency of the pharmacovigilance system in your company in accordance with regulatory requirements. The DrugCard pharmacovigilance platform will help automate routine activities and build transparent, validated processes.

  • Full automation of medical literature monitoring
  • Sources: EMA, WHO, FDA, MHRA, TGA, PMDA, Swissmedic, local Health Authorities websites and medical journals
  • Monitoring of reference medicinal products
  • Maintaining a comprehensive and standardized database of adverse reactions in accordance with the principles of ALCOA +
  • Export of adverse reactions according to E2B R2\R3 (XML format)
  • Integration with MedDRA medical dictionary
  • Data centers with information security management system according to ISO / IEC 27001: 2013
  • You will receive an effective electronic pharmacovigilance system that meets the regulatory requirements of local legislation and the international recommendations of the EU GVP.