Greeting from N2C President
While the pharmaceutical and the medical related business have been advanced at certain degree, with the continuous R&D activities by the related companies and their outsourcing of the associated works and with the deregulations by the Japanese government, the business environment also has been drastically changed and globalization has been progressed. For the Japanese CRO industry, the services to provide became various to deal with the various needs by the clients, as well as the increase of the responsibilities. It would be true that every company has been making their best efforts for the business.
However, in the pharmaceutical and the medical device industries in Japan, scandalous affairs have been repeatedly caused but unfortunately never ended. Besides, the issues of drug-/device-lag have not been solved yet, even though these were concerned and discussed for years, and it is often seen that the outcomes from researches in Japan seldom achieve to the business, even to the development phases. The presence of Japan in the world has been gradually but certainly faded out, while it used to have led the medical fields with the U.S. and the European counties.
As the causes of such issues, various factors have been identified and discussed. However, it is always pointed out that those were caused due to the consequences of human neglects; such as the performances and/or managements by incompetent personnel, inadequate usages of related systems, and/or the poor understandings of relevant regulations. While the works by the real professional personnel are required, especially for the works to develop the R&D strategies, it is questionable how many of the existing organizations in Japan can carry out their missions against the world.
To resolve such issues, it is required that skilled and experienced professional personnel develop the strategic approaches, aiming at not only R&D but also the exit for marketing, from the very early stages and that the qualified personnel manage the entire processes. Only through abolishing “man-made-disasters” and appointing and training right personnel, we can become the “true partner” for the clients, who can provide the appropriate services to meet the various needs by the clients. It is our mission to contribute for obtaining the NDA/MAH approvals by the clients, and to deliver the advanced technologies of pharmaceutical drugs, medical devices, and/or regenerative medicines for the patients, and this is the minimum condition as the sincere company which claims “contributions for human health and happiness.”
Therefore, this company, N2 Consulting, LLC., has been established, under the idea of “No means No;” which is famous words to express the sprits of the ancient Aizu Samurai. This words is often mistakenly understood only as “you should not do bad things,” however, this does not fully cover the actual meaning of the spirits. Together with the meaning of “you should do properly what you are supposed to do,” you come to fully understand the sprits. The word itself is very simple, however, for the R&D and the business works that require compliance to the laws and regulations, the sprit shows all about. Having this always in minds, the works to secure the speed and the quality would become naturally enabled.
We would create and provide new innovative values with the visions of global standards, contribute for finding and developing the seeds, and make the globally available medical technologies utilize in Japan too. In order to make these successfully delivered, we would serve for the social contributions without compromising in the quality of our duties, to deliver the new technology for patients as early as possible. Please kindly and continuously support our business.
February 27th, 2019
Founder & President Hirofumi OTSUKI
【Key Word】
Naranukoto-wa Naranu / Innovative Challenge in healthcare business / adequate measurements for global business standards / importance of strategic development