REGISTRATION/RE-REGISTRATION OF MEDICINES, FOOD SUPPLEMENTS, MEDICAL DEVICES, DISINFECTANTS/VARIATION TO REGISTRATION DOCUMENTS:
  • Audit of documents for registration needs;
  • Preparation of registration dossier according to Ukrainian legislation requirements;
  • Supporting of process of state registration;
  • Custom clearance of samples for quality control;
  • Supporting of process of quality control in accredited laboratory;
  • Label's drafting; preparing and agreement of labels in state authority;
  • Receiving of registration certificate;
  • Full consulting support of all registration process.


PHARMACOVIGILIANCE
  • Assistance in creation pharmacovigiliance organization chart in your company;
  • “Selective” pharmacovigiliance (preparing documents and conducting separate procedures of pharmacovigiliance system);
  • Training and education of employees for pharmacovigiliance system (urgent and system messages);
  • Creating and service pharmacovigiliance system for representative companies;
  • Collection and preparing documents for creating a PSUR (Periodic safety update report);
  • Support in creation a PSUR.


Ukrainian legislation