Development of a quality management system (QMS) for a product that is intended for use in a medical setting and has a therapeutic role but is not a medical device presents many challenges. æEffective quality systems hold significant promise in increasing PDP performance and efficiency for innovative Research and Development companies (R&D). æDialog between the R&D team and the QMS team establishes a comprehensive pathway from early concept feasibility through development and commercialization, allowing faster and more efficient progression through controlled development and effective resource allocation. æThe success of any PDP relies heavily on integration of the QMS with companyÍs culture and infrastructure. æQMS are designed to add controls during the PDP, thus ensuring effective development and reproducibility, and resulting in a quality product. æThe establishment of a QMS may have a lengthy development phase that can affect the companyÍs business strategy, but the benefits should outweigh the costs. ææThis presentation will describe first the principles and taxonomy of the relevant regulations. ææRegulations and the regulatory environment are affected by what is happening in the marketplace as well as developments in science and engineering. æThe challenge to the QMS team is to implement systems that are compliant with regulations, fit within industry standards and do not stifle innovation. ææSecond the development and planned implementation of a QMS with defined responsibilities will be described. ææææAn effective QMS provides many benefits for employees, the company and its customers. The goal has been ñSay what you do and do what you sayî.