Services:
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Development of a dossier in CTD and/or CTD ICH format (RU/EN), dossier translation;
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Introduction of changes to registration dossier of an authorized drug product;
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Development of individual dossier modules for dossier in CTD and/or CTD ICH format (RU/EN) formats;
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Translation and compilation of administrative dossier module;
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Development of draft Instruction for Medical Use and Regulatory Documents;
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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;
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Execution of the Safety module with organization of pharmacodynamic, pharmacokinetic and toxicological studies;
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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;