As we are faced with a paradigm shift of the social security system due to the aging of society in Japan, those engaged in the healthcare industry (including not only medical and care work providers, but also pharmaceuticals or medical device makers and other medical/nursing care related businesses) are in a severer business environment than ever before. Solid risk management strategies have become increasingly important in the medical and healthcare areas because a revelation of even one single legal risk incident could be a heavy blow to the basis of the entity’s whole existence. Meanwhile, the life science, including biotechnology, nanotechnology, chemistry and new medical drug development, and the healthcare industry, is becoming the field where a great potential for start-up businesses’ growth lies as a number of epoch-making inventions and business models have been developed along with today’s advancement of leading-edge technology. As we consider the healthcare and life science as one of the most important arenas that support the growth of Japan in the 21st century, we provide consultations and information concerning these areas, serving the legal needs of a significant number of our clients, through which we continue to further enhance our knowledge and build a solid foundation for our expertness in this field. Our attorneys are adept at these areas; many of them serve as directors or supervisors of medical or social welfare corporations, and we have attorneys with a medical license or working experience through secondment to the Japan Patent Office. These “expert” attorneys offer advice and guidance on healthcare-related laws and regulations as well as related compliance matters. Furthermore, we provide comprehensive services based on our accumulated knowledge and expertise in this area, from negotiations with the competent authorities concerning M&A, start-up businesses, etc. (including obtainment of, or examination for obtainment of, government approvals and license of medical devices and their clinical trials therefor, and responding to administrative guidance and inspections for medical care under the health insurance) to the crisis management and dispute resolution with regard to adverse events, complaints, misconducts etc. (including making reports and notifications, dealing with accident investigations and responding to administrative procedures) and to employment or labor management of medical personnel. We also assist medical/ life science-related start-up companies in developing and promoting their intellectual property strategies and internal control systems, and help them to go public by offering consultation on financing schemes. We offer general legal advice on the laws and regulations concerning research and development, manufacturing, sale and distribution, advertising etc. and on drafting contracts or preparing other related documents as well.