Case Study

Feasibility evaluation of obtaining OTC classification for two anti- inflammatory drugs

Feasibility evaluation of obtaining OTC classification for two anti- inflammatory drugs

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CLIENT SIZE THERAPEUTIC AREA GEOGRAPHY CASE STUDY: DISCOVERY / NON-CLINICAL CLINICAL DEVELOPMENT MARKETING AUTHORIZATION / APPROVAL PRODUCT MAINTENANCE Global Anti-inflammatory drugs Medium Pharma Feasibility evaluation of obtaining OTC classification for two anti- inflammatory drugs Verify legal status (Rx/OTC) and indications focusing on key markets worldwide Evaluation of clinical / non-clinical documentation (reports, literature) for switch candidates in comparison to main competitor Identification of unique selling points Recommendations for measures to obtain OTC status (e.g. indications, dosing and other posology changes, clinical studies) The client had developed two anti-inflammatory drugs The client needed support with: Feasibility evaluation about obtaining OTC classificatio

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