Office-KOBY Ltd offer cost-effective services including professional attention to the client's needs in a flexible arrangement of cost structures and service plans. We can provide consulting services and dossier preparation in science-based regulatory strategy with hands-on experience in Japan. Consulting services we offer can bring the medical product to Japanese market in a quickest and most cost effective way. We can evaluate and design the best regulatory strategy from product's existing data in order to gain the ideal path to Japanese MHLW approval under the new PAL.
- ・Establishing a best strategy for product registration and business in Japan
- ・Consultation for regulatory arrangement and preparation of documents
- ・Management and preparation of documents for preclinical/scientific studies
- ・Negotiation with MHLW and PMDA including STED requirements and MAH handling
- ・Preparation of GQP(Good Quality Practice) and GVP(Good Vigilance Practice)
- ・Preparation of application for QMS (Quality Management System) compliance
- ・Preparation of application for Foreign Manufacturers Accreditation
- ・Filing the applications(Approval/License) and communicating with the MHLW/PMDA
- ・Responding to inquiries after application and attending meetings with the MHLW/PMDA
- ・Find a third party in case of medical devices for which certification standards exists
- ・Preparation of reimbursement application documents and negotiation with the MHLW
- ・Preparation of Japanese labeling, directions for use and operations manual
- ・Assisting in arrangements of business meetings with Japanese companies
- ・Providing updated information on regulatory and marketing circumstances in Japan
For details of cost estimation, please contact us
- Company Name
- Office-KOBY Ltd
- Representative Director
- Isao Kobayashi(Personal Data)
- address
- No.101, 3-4-3
Nishiogi-Minami, Suginami-ku
Tokyo 167-0053 Japan - Established
- September 22, 2006
- Capital stock
- Three million yen
- Trading bank
- Sumitomo Mitsui Banking Corp,Nishiogikubo branch