definiens: means all activities related to research, pre - clini cal and other non - clinical testing, test method development and stability test ing, toxicology, formulation, process development, manufacturing scale - up, qualification and validatio n, quality assurance / quality control, Clinical Stud ies, including Manufacturing in support thereof, statist ical analysis and report writing, the preparation a nd submission of Drug Approval Applications, regulator y affairs with respect to the foregoing and all oth er activities necessary or reasonably useful or otherw ise requested or required by a Regulatory Authority as a condition or in support of obtaining or maintaining a Regulatory Approval . When used as a verb, means to engage in Development . For purposes of c larity, Development shall include any submissions and activities required in support ther eof, required by Applicable Laws or a Regulatory Authority as a condition or in support of obtaining a pricing or reimbursement approval for an approve d Licensed Product