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.
- 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.