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Orphan Drug Applications

RPN provides support for the preparation of Orphan Drug Designation Applications in EU and USA. On the basis of the data provided by the client, RPN prepares the application including details on the target condition, the proposed indication and the medical plausibility, a justification of the life-threatening or debilitating nature of the condition, information on the prevalence of the condition and on the existence of other methods of diagnosis, prevention or treatment. In addition, RPN takes care of translations of the active substance and proposed indication in all EU languages.