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Registration of drugs/medical devices/dietary supplements

Registration of drugs/medical devices/dietary supplements

Vita Aeterna company offers the complex package of services for state drug registration and its confirmation, as well introduction of changes to a registration dossier of authorized drug products in Russia, Kazakhstan, Belarus, Armenia, Kirgizia with the full support of a registration process. Registration of medical devices. Registration of dietary supplements

Services:

  • Development of a dossier in CTD and/or CTD ICH format (RU/EN), dossier translation;

  • Introduction of changes to registration dossier of an authorized drug product;

  • Development of individual dossier modules for dossier in CTD and/or CTD ICH format (RU/EN) formats;

  • Translation and compilation of administrative dossier module;

  • Development of draft Instruction for Medical Use and Regulatory Documents;

  • Development of Quality module, arrangement of incoming contrоl, development of validation protocols, verification and execution of validation reports (control methods, manufacturing processes), stability study, dissolution kinetics study;

  • Execution of the Safety module with organization of pharmacodynamic, pharmacokinetic and toxicological studies;

  • Execution of the Efficacy module with arrangement of bioavailability and bioequivalence studies, pharmacodynamic, pharmacokinetic and clinical trials, post-authorisation clinical studies, analysis of the post-authorisation experience of use, correlation analysis of results in vitro – in vivo; 


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