Advance your journey to Japan with EPS.

Starting a new business in a foreign country is a completely new challenge for anyone and any company. Each country has a long history and a lifestyle and culture that is rooted in that history. When considering expanding pharmaceutical business to a different country, there are differences not only in pharmaceutical regulations and medical systems, but also in customs, culture, and language. In addition, each country has many unique characteristics that are difficult to understand by foreigners. Although efforts have been made to harmonize and standardize pharmaceutical development, marketing, and sales on global basis, the uniqueness of each country that has been cultivated over many years remains.

For Japan to continue to be one of the leading countries in the world for pharmaceutical business, Japan is currently promoting regulatory reforms to make entering the Japan pharmaceutical market easier for non-Japanese companies. Now it is the perfect time to think about expanding your business into Japan. Why not bring your valuable pipeline to Japan?

Getting borderless in Japan

Japan is ranked among the top three countries in the world in the pharmaceutical market and is working on several measures to further lead the world as a leading pharmaceutical country. In December 2023, new guidelines were issued and now many considerations are being made by the Japan Ministry of Health and Welfare. One of these guidelines states that, depending on certain caveats, a Phase I trial in Japan before joining a Multi-Regional Clinical Trial (MRCT) is not necessary (as had previously been the case). Other guidelines include reviewing the orphan drug designation system and promoting the development of pediatric drugs. We strongly believe that these are great breakthroughs and now it is the perfect time to enter the Japanese market.

For the past 30 years, EPS have been providing CRO services specializing in clinical development support and have been widely recognized and highly praised by various stakeholders in Japan. We have experience conducting over 1,000 clinical study protocols in oncology, over sixty clinical study protocols in the regenerative medicine field, and over two hundred clinical study protocols in rare diseases. Additionally, we have conducted many multi-national joint clinical studies both domestically and internationally. We are also actively pursuing new initiatives such as DCT (Decentralized Clinical Trial), promotion of patient participation in clinical studies which is a topic of ICH E6R3 Annex2 as well as RWD utilization.

Utilizing this strength to provide one-stop support for the development and commercialization of innovative new drugs and new modalities in Japan, as well as post-approval processes, EPS will become an opportunity creator for start-ups to help deliver innovation to Japanese patients.

EPS, which knows everything about Japan, will take on the challenge of this reform and create opportunities in Japan for excellent overseas pharmaceuticals. We would like to review Japan from an overseas perspective and create the best solutions from the perspective of Japanese medical institutions and patients.

Thus, EPS is implementing a number of measures to encourage entry into the attractive Japanese pharmaceutical market.

EPS has begun collaboration with Frontage Laboratories, Inc. (USA) to promote implementation of Phase I studies including Japanese healthy volunteers in the United States.

Creating new solutions

Companies around the world are working to utilize big data and build evidence in the healthcare field. EPS has started a collaboration with NTT Data, one of Japan's largest companies in this field, and EPS is also collaborating with multiple companies for contributing to evidence building and leveraging EPS's 30-plus years of experience. We believe that by leveraging each company's areas of expertise, we will accelerate the development of new solutions. Would you like to collaborate with EPS, become a member of the drug development ecosystem, and create new solutions?

"We understand the unique challenges of entering the Japanese market and can help you navigate the process smoothly," states Noriyuki Takai, Executive Corporate Officer, EPS Corporation

In addition, although SMO services have developed independently in Japan, we are promoting innovation by further improving efficiency, increasing speed, reducing costs, and ensuring data integrity by integrating a part of the functions of CRO and SMO. EP-Link, which provides SMO services within the EPNextS group, is Japan's largest SMO company, and we believe that this initiative will bring about major changes in drug development in Japan.

Our mission

At the EPNextS group of companies (comprised of EPS’ CRO, SMO, and CSO businesses), we aim to shorten drug development by as much as possible, deliver groundbreaking treatments to patients as quickly as possible, and accumulate a wide range of treatment evidence after launch to spread safe and effective treatments. To achieve this, we will continue to evolve with the following four “S” keywords.
● Service: Develop a high-quality service supply system by building on the experience and expertise we have cultivated over the years.
● System: Build a system that allows new initiatives.
● Solution: Create innovative business solutions in the healthcare field.
● Stage: Move into the next stage as a new business entity that combines the three core businesses of CRO, SMO and CSO.