The Contractor shall conduct program analysis activities upon request and provide on-site staff to assist in creation of product development plans for vaccines and therapeutics. The Contractor shall provide information and knowledge in areas including but not limited to: product (vaccine or therapeutic) development analysis; creation of target product profiles; preclinical strategy; manufacturing capacity analysis; regulatory strategy; clinical development strategy with transition plan to advanced phase clinical testing; candidate down-selection strategy; and market analysis of public-private partnerships. The Contractor shall identify deficiencies in these areas, and independently close those deficiencies using their skills and abilities and those of subcontractors. The Contractor shall maintain a Quality Control/Quality Assurance (QC/QA) program to monitor performance, including the development of standard operating procedures (SOPs) for each protocol or process, optimized for maintaining the integrity of human biological material; for monitoring the quality of products; for the operation of the laboratories; and for tracking specimen influx, processing, and efflux.