KBIO Solution is a company that provides license consulting fort US FDA, MDR CE in Europe, MFDA and CRO services for conducting clinical research. KBIO also provides business consulting for medical device company. Since its establishment in 2016, KBIO has signed FDA 510 (k), CE certification, GMP and clinical research contracts with more than 60 medical device manufacturers over the past six years, and has been working on MDR consulting projects for a total of 17 items, including Johnson & Johnson's US headquarters.

Other consulting companies additionally outsource FDA approval contracts to a third party consulting company in the United States, and there are frequent cases of approval failures and rejections. On the other hand, KBIO conducts FDA and MDR CE consulting and licensing work directly to the end, starting with CEO Kang Kyung-yoon, who has gained expertise in licensing at multinational companies Cardinal Health, St. Jude Medical, and Cook Medical. In response to the growing need for FDA experts, CEO Kang was invited to the Ministry of Food and Drug Safety to give a licensing lecture for the entire medical device licensing department, and was also featured in the TV program of the Money Today broadcaster in Korea.

KBIO also developed a CRO clinical trial management project and obtained official approval from the Ministry of Food and Drug Administration for a Phase II clinical trial of a new drug at Asan Hospital in 2021. Three major hospitals in Korea successfully completed large-scale clinical trials from initial design to monitoring, statistical analysis, and clinical conclusion. In 2022, he is in charge of clinical trials of medical devices for the treatment of bile duct stenosis at Inha University Hospital and Seoul Asan Hospital, and has completed clinical trials at UCLA in the United States and is preparing for clinical progress at State University of New York in September 2022. As a result, we are making full efforts to respond to the increasing number of licensing/clinical CRO projects.