合同会社Dr. Shu Office / Dr. Shu Office LLC
体外診断用医薬品(IVD)のPMDA申請、並びに付随するQMS業務
PMDA Regulatory Submissions for In Vitro Diagnostic (IVD) Products and Related QMS Services
Details →CMC研究全般、並びにFDA、PMDAへのCMC申請業務
CMC Research and Development, Including CMC Regulatory Submissions to FDA and PMDA
Details →化粧品、医薬品、サプリの広告、並びに当局提出文書の薬事チェック
Regulatory Check of Documents of Cosmetics, Pharmaceuticals, and Supplements for Advertising in Japanese Market and Regulatory Submission to Japanese Authorities
Details →医学・バイオ・医薬品開発に向けた英語、日本語、フランス語、韓国語、並びに中国語教室
English, Japanese, French, Korean, and Chinese Language Courses for Medicine, Biotechnology, and Pharmaceutical Development
Details →英語、日本語による日本におけるRA、QA、QMS(ISO13485、QMS省令（厚生労働省令第169号）)教室、並びに付随する教育・訓練
RA, QA, and QMS Training in Japan in English and Japanese, Including ISO 13485 and Japan’s QMS Ordinance (MHLW Ministerial Ordinance No. 169), as well as Related Education and Professional Training Services
Details →日本の科学技術と伝統の結晶である２年間冷蔵・冷凍不要の本格和食「うちのや “UCHINOYA”」の海外展開
Global Expansion of “UCHINOYA,” Authentic Japanese Cuisine Combining Japanese Science, Technology, and Tradition, with a Two-Year Shelf Life Without Refrigeration or Freezing
Details →病院・クリニック経営改善支援事業
Hospital and Clinic Management Improvement Consulting Services
Details →私たちは、医薬品(CMC)・体外診断薬(IVD; RA、QA、QMS)、並びに化粧品をはじめとするメディカル製品の広告等薬機法チェック業務を中心とした、7種の事業を展開しています。
各分野において科学・法規・経営学の深い理解から貴社のメディカルビジネスを支援いたします。
合同会社Dr. Shu Officeの全コンサルタントは、世界で勝負ができる医師、博士号保有者（Ph.D. 医学・薬学・理学）、薬剤師、MBA保有者、経営コンサルタント、弁護士です。
We are operating 7 Business, with a primary focus on RA, QA & QMS of in vitro diagnostics (IVDs), RA & RD of CMC, and regulatory check of advertising materials of Cosmetics and other Medical Products in Japanese Market.
We support your Medical Business through our deep expertise in SCIENCE, REGULATION, and ECONOMICS.
All consultants at Dr. Shu Office LLC are highly qualified professionals capable of working at a global level, including Physicians, Ph.D. holders in medicine, pharmaceutical sciences, and science fields, Pharmacists, MBA holders, Management Consultants, and Attorneys.
| 医師（M.D.） | Medical Doctors |
| 博士号保有者（Ph.D. 医学・薬学・理学） | Ph.D. holders |
| 薬剤師 | Pharmacists |
| MBA保有者 | MBA holders |
| 病院・クリニック経営コンサルタント | Hospital & Clinic Management Consultants |
| 弁護士 | Attorneys |