Abstract
Most of RD, technological and experimental works carried out in Russia result in the development of technologies with low-level readiness for possible integration into the production cycles of industrial enterprises, which, on the one hand, demonstrates a lack of understanding by developers of the requirements for the product life cycle, and on the other hand, it is the possible reason for the low share of Russia in the total world exports of high-technology goods. In order to create a scientific and technical reserve in a target time, the world practice uses the Technology Readiness Levels (TRL) scale. This approach is used in various industries and has shown the possibility to develop technologies and launch production of innovative product by a target time. However, the Ministry of Education and Science notes that this approach has not yet been used to determine the readiness levels of chemical-technological processes and pharmaceutical technologies. The article discusses main scientific problems associated with conducting a comprehensive assessment of technological readiness levels of an innovative project during the development of a pharmaceutical product, using the TRL scale and the QbD concept for a systematic and early approach to development, based on a scientific understanding of the drug life cycle processes.
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