As experts in pharmaceutical development in Japan, our consultants possess extensive experience, and they value teamwork.

And understand your needs and build trust through transparency and open communication.

Among our exprets, 5 experts, see below, are newly joined for your support.

Keiji Sawamukai
He has a wide -range of pharmaceutical business skill and
well-known of these activities.
  • At three Japanese pharmaceutical companies and three major global pharmaceutical companies, he has been responsible for clinical monitoring, SOP management, therapeutic drug management, QC&QM of clinical trials, statistical analysis, clinical data management, medical writing, and regulatory submissions.
  • As a topic leader of the Japan Pharmaceutical Manufacturers Association (JPMA) at the ICH expert meeting, he was involved in the development of ICH-E2bM2 and CTD electronic guidelines.
  • He served as the leader of the Electronic Standards for Medical Information (ESMI) and participated in the development of the ER/ES guidelines as a representative of the industry, and was involved in its creation.
  • He established the new electronic information committee within the JPMA, served as the first committee chairman, and participated in the medical information infrastructure network council as a representative of the JPMA (Ministry of Health, Labour and Welfare).
  • In addition, he serves as a DIA program committee member, a director of the Public Ware Promotion Organization NPO-MIST, and is currently active as a lecturer at the Clinical Data Management (CDM) seminar sponsored by the Union of Japanese Scientists and Engineers (JUSE).

Yoshitaka Ichikawa
He has strong leadership focusing on various on-site activities.
  • Engaged in drug discovery and development research at a research institute of a foreign pharmaceutical company where he developed highly sensitive analytical methods using mass spectrometry, and particularly promoted their application to drug metabolism research.
  • Involved in preclinical development (safety and pharmacokinetics), R&D project management, portfolio management work, and served as the leader of multiple projects.
  • In the field of clinical development, he was responsible for overseeing clinical trials, formulating clinical trial protocols, monitoring, medical writing, and new drug application processes.
  • At a domestic CRO, he worked as a senior consultant for regulatory affairs consulting, and has experience as a development project leader (concurrent) and regulatory affairs consultant in the rare disease department.

Toshikazu Yoshinaga
He has a good communication skill for pharmaceutical business activities.
  • As an ICH coordinator of the Japan Pharmaceutical Manufacturers Association, he is responsible for coordinating ICH meetings, supporting the establishment of JMO (MedDRA), and assisting in the management of the overall ICH4 general meetings.
  • Based on his experience at the safety research institute of a domestic pharmaceutical company, he is responsible for global development and new drug applications in the United States and Europe from the standpoint of Japanese companies.
  • At a foreign pharmaceutical company, he is in charge of regulatory negotiations to eliminate drug lag (including development strategies, face-to-face advice, and director-level discussions), and new drug application work.
  • At a venture company, he is in charge of formulating corporate development strategies for regenerative medicine and anticancer drugs, overseeing all development and application processes, and achieving regulatory approvals in a short period of time.
  • As a regulatory affairs specialist of a CRO, he is responsible for explaining Japanese pharmaceutical regulations to overseas clients and creating regulatory-related documents.

Takeshi Adachi
He has a strong connection with China.
  • He has been active as an expert in biostatistics and clinical data management in pharmaceutical development at domestic companies.
  • He became a director after moving to a major CRO that was in its infancy. After working as a representative of several subsidiaries as a business development manager, he became independent. During this period, he was involved in the entry of many Japanese companies, starting with pharmaceutical companies, into the market of the People's Republic of China.
  • Afterwards, he participated in the management of a Sino-Japanese joint venture with the highest-ranking medical institution group in the People's Republic of China.
  • In addition, he has a history of serving as a director of a post-marketing related academic society in the People's Republic of China and working as a researcher at national and public universities.

Koji Iwamoto
He has extensive knowledge of clinical development through to post-marketing.
  • Working on Diagnostic NDA submission, its review process, and obtained approvals, as well as drug price negotiation (Full development until launch).
  • First FD application was made and many IT systems (including CSV support) introduced leading to improve business processes.
  • Through these experiences and using people management skills, business processes was re-established. And, his education was given to junior staff and grown up them to managers.
  • He worked for JPMA's ESMI study group and EI subcommittee on various computerization support (including ICH support), and CDISC support at the Japan CRO Association.

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DOT WORLD Co., Ltd. Comodio Shiodome 4F, 2-14-1
Higashi-Shimbashi, Minato-ku, Tokyo, 105-0021, Japan