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In international regulatory practice, there are special programs for the accelerated registration of innovative medicines and medical devices (breakthrough therapy, accelerated approval, a special program for antibiotics effective for infections caused by highly resistant microorganisms). Special consultations of the applicants with the regulatory agencies or centers (FDA, EMA, PMDA, KFDA etc.) at all stages of the development make it possible to maintain the most efficient dialogue between the developer and the authorized authority.
Vice President, Head of Strategic Projects of Global External Innovation & Alliances
Government of Moscow Department of Healthcare Scientific Research Institute of Healthcare Organization and Medical Management
Director, Corporate Communications and Legal Affairs, Russia and Eurasia