definiens: means all activities related to pre - clinical and other non - clinical research, testing, test method development and stability testing, toxicology, form ulation, process development, manufacturing scale - u p, qualification and validation, quality assurance / qua lity control, Clinical Studies, including Manufactu ring in support thereof, statistical analysis and report writing, t he preparation and submission of Drug Approval Appl ications, regulatory affairs with respect to the foregoing, a nd all other activities necessary or reasonably use ful or otherwise requested or required by a Regulatory Authority as a condition or in support of obtaining or maintaini ng a Regulatory Approval . When used as a verb, means to engage in Development . For purposes of c larity, Development shall include any submissions ( and acti vities required in support thereof ) required by App licable Laws or a Regulatory Authority as a condition or in support of obtaining a pricing or reimbursement ap proval for an approved molecule or product