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 Global Various Top 20 Pharma company M&A Regulatory Support – Initial Situation Preparation and support of MAH transfer submission packages including authority contacts Clarification of any open items with local sites during MAH transfer Regulatory strategies and corresponding activities for selected countries, for which a MAH transfer application is not possible but requires a new marketing authorization application Risk assessment/management to contribute to a smooth MAH transfer process while supporting ongoing variations, timing of

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