development or develop

development or develop. Means, with respect to a Product or Excluded New Product, all research, preclinical, pharmaceutical, and clinical activities and other activities undertaken in order to obtain Regulatory Approval of such Product or Excluded New Product, including all preclinical and clinical drug development activities, research, test method development and stability testing, toxicology, animal studies, statistical analysis and report writing, clinical trial design and performance prior to obtaining Regulatory... Approvals, and regulatory affairs related to the foregoing. "development" will also include relevant formulation, process development, manufacturing, manufacturing scale-up, current Chemistry and Manufacturing Controls section of an IND, development-stage manufacturing, quality assurance, and quality control development. View More