Although our company is Pharmacovigilance Agency, we also provide basic registration services. Our specialists closely follow the industry trends, know the issues, detailed features of the registration process and current requirements, which allows our organization to provide full support to the dossier at all stages of registration.
- Formation, submission and full support of the registration dossier
- Harmonization of the registration dossier with the requirements of the EAEU
- User testing of the package insert
- English-Russian translations/verification of documentation for drug registration
- Consulting services for registration
- Preparation of a safety monitoring form for confirmation of state registration of a medicinal product (“re-registration” of a registration certificate for an indefinite period)