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.