Sustainable development regulatory requirements

The problem of chiral synthesis is critical in making pharmaceuticals. Researchers at GlaxoSmithKline, AstraZeneca and Pfizer have examined 128 syntheses from their own companies and found that as many as half of the drug compounds made by their process R D groups are not only chiral but also each contains an average of two chiral centers [ 15 2]. To meet regulatory requirements, enantiomeric purities of 99.5% were found to be necessary. Biocatalysis is thus an essential tool for pharmaceutical research, and contributes to the development of more sustainable processes. 

The costs of research and development as a result of regulatory requirements will diminish the number of laboratories competing. Only those corporations with the size and capital needed to sustain the long and expensive developmental process will be able to persevere. 

The practical application of the developed method is limited, mainly due to the regulatory requirements imposed on the nuclear power plants in order to sustain and verify their safety. With the change of the regulatory requirements and increasednnmber of components which will go under on-hne maintenance, the practicality of maintenance schedule optimization algorithms is expected to increase. 

A large variety of skills and resources are required to develop a product from concept to regulatory approval and commercial sale. For NPD it has been found that the presence of both functional and integrative capabilities is often positively correlated with NPD process efficiency, measured in terms of lead time, productivity, and product effectiveness. Sustained above-normal returns for a firm can come both from an NPD process that is faster and more productive than competitors , and from new products that create customer value through their overall quality and ability to lit with market needs. As shown in Figure 16.3, in order to develop a product successfully, six types of product development capabilities are required. 

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