The Regulatory Office participates to the definition of the more opportune registration strategy in order to obtain a marketing authorization (MA); prepares the registration dossier, filling, in a critical way, data collected by the various departments involved in the preparation the new product: Research and Development, Quality Assurance, Microbiological and Chemical Analysis Laboratories, Physical and Chemical validation Laboratory, Scientific Service. It also prepares, together with the involved Services, the documentation needed from the Authority in charge to determine the Medicinal Product selling price; it manages, after obtaining a marketing authorization, any possible change to it and constantly interfaces with the Medicines Agencies.