In the development of ethical pharmaceuticals and the preparation of documents for new drug application, especially in the area of quality, globalization is becoming more pronounced with the establishment of ICH guidelines and the progress of pharmacopoeia harmonization. On the other hand, with advances in science and technology, pharmaceuticals come in a wide variety of forms, and the complexity of development research and manufacturing management has increased dramatically. In addition, for foreign pharmaceutical companies and domestic pharmaceutical companies considering in-licensing from foreign pharmaceutical companies, there are still high hurdles to overcome in the development of ethical drugs and preparation of application materials for approval in Japan due to Japan-specific requirements and language barriers. Under these circumstances, I founded JAPAN CMC Inc. with the hope of assisting pharmaceutical companies planning to develop and submit applications for approval of ethical drugs in Japan. After building my career as a professional and manager in the CMC regulatory affairs department for over 15 years at the Japanese subsidiaries of several medium-sized to large foreign pharmaceutical companies, I have been in charge of my responsibilities as a senior consultant and department head for over seven years at IDEC Co., Ltd. (now Eliquent Japan Inc., https://eliquent.jp/), a pioneering pharmaceutical consulting company covering a wide range of fields in Japan. I believe that the experience and knowledge I have gained in these positions will enable me to assist pharmaceutical companies in all aspects of quality, from development strategy planning, preparation of regulatory submission materials, review responses, and post-marketing change management.

JAPAN CMC Inc.
Representative Director Takeshi Miyamoto