definiens: means : ( a ) research activities ( including drug di scovery, identification, or synthesis ) with respect to a product ; or ( b ) preclinical and c linical drug development activities and other devel opment activities with respect to a product, including tes t method development and stability testing, toxicol ogy, formulation, process development, qualification and validation, quality assurance, quality control, Cl inical Trials ( including the conduct of Clinical Trials and other trials commenced after Regulatory Approval ), stati stical analysis and report writing, the preparation and su bmission of INDs and MAAs, regulatory affairs with respect to the foregoing, and all other activities necessar y or useful or otherwise requested or required by a Regulatory Authority or as a condition or in support of obtain ing or maintaining a Regulatory Approval . For clari ty, does not include Manufacturing . When used as a ve rb, means to engage in Development