CASE STUDY: CLIENT SIZE THERAPEUTIC AREA GEOGRAPHY DISCOVERY / NONCLINICAL DISCOVERY / NONCLINICAL DISCOVERY / NON-CLINICAL DISCOVERY / NON-CLINICAL DISCOVERY / NON-CLINICAL CLINICAL DEVELOPMENT MARKETING AUTHORIZATION / APPROVAL PRODUCT MAINTENANCE US Opthamology Large pharmaceutical Rx-to-OTC Switch Safety Support CLIENT NEED OUR SOLUTION PHARMALEX VALUE TO CLIENT The client was a large pharmaceutical company with offices worldwide Client was seeking an OTC indication for established Rx product The OTC product has a different indication and is intended for a broader population PharmaLex was enlisted to conduct adverse event analyses in five safety databases and a literature review in support of the Rx-to-OTC NDA submission Timelines: Pre-NDA meeting support/attendance (1 month) A

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