Cobridge Co., Ltd. of Tokyo at MEDICA 2018 in Düsseldorf -- MEDICA - World Forum for Medicine
Service

Cobridge Co., Ltd.

KDX Kojimachi Bldg. 5F, 3-3-4 Kojimachi, Chiyoda-ku, 102-0083 Tokyo
Japan
Telephone +81 3 52753570
Fax +81 3 52753577
info@cobridge.com

Hall map

MEDICA 2018 hall map (Hall 16): stand A41

Fairground map

MEDICA 2018 fairground map: Hall 16

Contact

Hiroko Yamaguchi

Tokyo, Japan

Phone
81 3 5275 3570

Email
info@cobridge.com

Visit us

Hall 16 / A41

12.11.2018

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Consultation and regulatory support for your products entrant into Japan

Cobridge is a regulatory affairs consulting firm that provides comprehensive product-registration services and the Designated Marketing Authorization Holder (DMAH) services for medical devices in Japan.

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13.11.2018

Topic

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all-day

Consultation and regulatory support for your products entrant into Japan

Cobridge is a regulatory affairs consulting firm that provides comprehensive product-registration services and the Designated Marketing Authorization Holder (DMAH) services for medical devices in Japan.

More Less

14.11.2018

Topic

Download

all-day

Consultation and regulatory support for your products entrant into Japan

Cobridge is a regulatory affairs consulting firm that provides comprehensive product-registration services and the Designated Marketing Authorization Holder (DMAH) services for medical devices in Japan.

More Less

15.11.2018

Topic

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all-day

Consultation and regulatory support for your products entrant into Japan

Cobridge is a regulatory affairs consulting firm that provides comprehensive product-registration services and the Designated Marketing Authorization Holder (DMAH) services for medical devices in Japan.

More Less

Our range of products

Product categories

  • 07  Medical Services and Publications
  • 07.17  Other medical services and publications

Our products

Product category: Other medical services and publications

We support non-Japanese manufacturers considering entering into Japanese medical device market

Cobridge is a regulatory affairs consulting firm:
We provide comprehensive product-registration services for medical products in Japan, in formulating best cost-effective regulatory strategies, in preparing application documents, and in communicating with the Ministry of Health, Labor and Welfare (MHLW) and the Pharmaceuticals and Medical Devices Agency (PMDA).

PMDA meeting:
We arrange, prepare Briefing Documents (BD) and conduct pre-clinical, clinical, and pre-approval consultation meetings with the PMDA on behalf of or with our overseas clients.

Approval application serivces and DMAH services for post-approval:
For the oversea manufacturers of medical devices, we prepare and file new product approval applications (shonin-shinseisho and STED) or third-party certification applications (ninsho-shinseisho) by acting as the Designated Marketing Authorization Holder (DMAH) throughout the process from application to post-marketing stage. 
We also prepare medical device pricing applications, and reimbursement applications for procedural fees for submission to the Economic Affairs Division, Health Policy Bureau, MHLW. 

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Company news

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Jul 27, 2018

Cobridge is a member of WDB Group.

WDB Holdings is a leading player in the human resource services and Contract Research Organization (CRO) business arenas in Japan.

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About us

Company details

Cobridge is a regulatory affairs consulting firm that provides comprehensive product-registration services for medical products in Japan, in formulating best cost-effective regulatory strategies, in preparing application documents, and in communicating with the Ministry of Health, Labor and Welfare (MHLW) and the Pharmaceuticals and Medical Devices Agency (PMDA).

The company was founded in 1999 by Joseph Coveney, Ph.D., and Akemi Minegishi, Ph.D.  It has its offices in central Tokyo, in the Chiyoda district, near the legislative and other governmental buildings.

All of our technical staff are native-Japanese speakers who can interpret the often difficult-to-apprehend meaning of Japanese regulatory pronouncements. Nevertheless, the staff’s strengths include facility in English and, unlike with other consulting firms where the staff with good English skills are typically not graduates with technical degrees, our staff’s ability to handle technical documentation in English is based upon a scientific background which lends the ability to interpret, not only translate. This combination of technical background and English language skills lays the groundwork for not only understanding the technical documents that are the foundation of regulatory dossiers, but also for personal interaction that characterizes telephone and video conferences with our overseas clients during the progress of their projects.

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Company data

Sales volume

1-9 Mio US $

Number of employees

1-19

Area of business

Medical Services and Publications