CLIENT SIZE THERAPEUTIC AREA GEOGRAPHY CASE STUDY: DISCOVERY / NON-CLINICAL CLINICAL DEVELOPMENT MARKETING AUTHORIZATION / APPROVAL PRODUCT MAINTENANCE EU Oprhan product Medium Pharma Development plan for Immune suppressant in a specific indication within the Orphan Condition tuberous sclerosis CLIENT NEED OUR SOLUTION PHARMALEX VALUE TO CLIENT Immune suppressant to be applied as subcutaneous application in a specific indication Client aimed for a hybrid application with reference to the originator Additional own studies need to add up for a new indication and administration form PharmaLex offered support with: Proposing the regulatory strategy for EU and US: including Protocol assistance, PIP (partly waiver) / PSP Identifying bridging studies for preclinical development taking into

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