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Simultaneous improvement in development time, cost and quality: a practical framework for generic pharmaceuticals industry

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Abstract

Generic pharmaceutical companies strive to develop generic versions of drugs to obtain marketing rights after those drugs go off patent. Being a highly competitive industry, these companies have to work towards simultaneously reducing the development time and costs while meeting all the quality standards. While the literature has discussed the multiple trade-offs in product development, there is limited research on how the companies can break these trade-offs and simultaneously improve performance on multiple objectives and particularly in the context of the generic pharmaceutical industry. In this research, we try to bridge this gap and develop an improvement framework for simultaneously achieving the objectives in terms of development time, cost and quality. We apply the framework in a generic pharmaceutical company by redesigning its new product development process following Six Sigma methodologies and demonstrate the benefits through pilot projects with varying levels of complexity. The results show that a well-designed process which facilitates process standardization, optimization and collaboration can help in simultaneously achieving improvements in development time, cost and quality.

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