お問い合わせの方 03-6659-8083

ご来社の方 東京本社 / 大阪事業所

Mar 7

Description of Business

Monitoring of Pharmaceuticals & Medical Device

  • Explanation of Protocol and case report forms for primary investigator and its agreements.
  • Request of clinical trials to medical institution and perform procedures for Contract of clinical trial.
  • Correspondence with the results of IRB(institutional review board) deliberations.
  • Working out of start-up meeting.
  • Visiting medical institution to transmit information.
  • Collection and checking of case report forms.
  • Carrying out the source document verification.
  • Produce the report on monitoring.

Regulatory affairs related service of Medical Device

    1) Regulatory affairs consulting

    • Investigation of application category; certification or approval.
    • Planning from marketing approval/certification application through obtaining marketing approval/certification.
    • Investigation of application dossier and consulting.
    • Support for interview between third party certification organization and reviewing authority.
    • Support for other regulatory affairs related items.

    2) Items regarding marketing approval/certification application and marketing notification

    • Required information submission for preparation of marketing approval/certification application and marketing notification.
    • Support for preparation of marketing approval/certification application, STED (Summary of technical document) and attached data.
    • Support for preparation of various notifications.
    • Place an order for examination with outside research organization and its progress management.
    • Support for responding third party certification organization and PMDA (pharmaceutical and medical device agency) inquiry.
    • Support for other regulatory application related items.

Supporting medical device entry into Japanese market

  • Application for license for marketing authorization holder.
  • Application for accreditation of foreign manufacturers.
  • Application for license of manufacturing package, labeling, storage for domestic use.
  • Service as designated marketing authorization holder for foreign manufacturers.
May 26

Inquiry

Please fill out the necessary information on the inquiries form to submit your inquiries.

MORE Medical privacy policy (required-reading) and Inquiry form

At MORE Medical Inc., we are fully aware of the importance of handling personal data. And for the complete privacy policy, we are addressing a standardized understanding of it in the office which includes all board members and employees. We are stlongly commited to protecting Private Information Protection Law and the privacy policy that we set out.

1. About collection of personal data
Persosnal data which were collected in this site is managed by MORE Medical Inc. When we collect personal data, we will indicate the purpose of use beforehand and use them within that scope.

2. About use of personal data
We will indicate the purpose of using personal data which we collected from the site of “Contact us”. And we will not use such personal data outside the scope.

3. About provision of personal data
We will not provide personal data which we collected to a third-party without your consent. However, we may provide personal data when we have to disclose them according to law.

4. About management of personal data
We will manage personal data which we collected based on our privacy policy by placing chief privacy offer.

5. About “Cookies”
On this site we may use “Cookies” considering your convenience. A “Cookies” is a small piece of information which is sent to your browser and stored on your computer’s hard drive.
“Cookies” can be used for tracking browsing behavior but “Cookies” as used by us cannot be used to discover the identity of an individual user such as name or address. You can set your browser to deny when you receive a “Cookies” but please understand that this may not enable you to print or use the service of this site.

6. About inquiry, correction , and deletion of personal data
If you wish to inquire, correct, or delete your personal data which we collected, please contact us to the address indicated in the bottom of this page. After the identity is confirmed, we will correspond based on our privacy policy.

7. About continuous improvement of the handling of personal data
We will continuosly improve our privacy policy to adapt to the social changes.

8. To use this site
Please use this site with the understanding and consent of privacy policy.

[Contact info inquiries regarding privacy policy]
MORE Medical Inc.
Hisamatsu Bldg. 3F, 10-10 Nihonbashi Hisamatsu-cho, Chuo-ku, Tokyo, 103-0005 Japan.
TEL: +(81)-(0)3-6659-8083
FAX: +(81)-(0)3-6659-8093

Please fill in the form below













MOREMedical Inc., 11/2007 1st edition enacted

May 26

Company

Company Name MORE Medical Incorporated
Date of Foundation November 19th 2007
Capital 91,500,000 Japanese Yen
Location Tokyo Head Office;
Hisamatsu Bldg. 3F, 10-10 Nihonbashi Hisamatsu-cho, Chuo-ku, Tokyo, 103-0005 Japan.
TEL:+(81)-(0)3-6659-8083
FAX:+(81)-(0)3-6659-8093
Map

Osaka Office;
Sanko Bldg. 507, 1-8-2 Nishihommachi, Nishi-ku, Osaka, 550-0005 Japan.
TEL:+(81)-(0)6-4395-5812
FAX:+(81)-(0)6-4395-5551
Map
Board Member President, CEO
Director
Director
Yuichi Takemoto, D.V.M.,MS
Kiyoshi Onishi
Hirokuni Amari, M. Sc.
Description of Business Monitoring of Pharmaceuticals & Medical Device

  • Explanation of Protocol and case report forms for primary investigator and its agreements.
  • Request of clinical trials to medical institution and perform procedures for Contract of clinical trial.
  • Correspondence with the results of IRB(institutional review board) deliberations.
  • Working out of start-up meeting.
  • Visiting medical institution to transmit information.
  • Collection and checking of case report forms.
  • Carrying out the source document verification.
  • Produce the report on monitoring.

Regulatory affairs related service of Medical Device

    1) Regulatory affairs consulting

    • Investigation of application category; certification or approval.
    • Planning from marketing approval/certification application through obtaining marketing approval/certification.
    • Investigation of application dossier and consulting.
    • Support for interview between third party certification organization and reviewing authority.
    • Support for other regulatory affairs related items.

    2) Items regarding marketing approval/certification application and marketing notification

    • Required information submission for preparation of marketing approval/certification application and marketing notification.
    • Support for preparation of marketing approval/certification application, STED (Summary of technical document) and attached data.
    • Support for preparation of various notifications.
    • Place an order for examination with outside research organization and its progress management.
    • Support for responding third party certification organization and PMDA (pharmaceutical and medical device agency) inquiry.
    • Support for other regulatory application related items.

Supporting medical device entry into Japanese market

  • Application for license for marketing authorization holder.
  • Application for accreditation of foreign manufacturers.
  • Application for license of manufacturing package, labeling, storage for domestic use.
  • Service as designated marketing authorization holder for foreign manufacturers.
May 26

Location

Tokyo Head Office

  • Hisamatsu Bldg. 3F, 10-10 Nihonbashi Hisamatsu-cho, Chuo-ku, Tokyo, 103-0005 Japan.
  • Tel: +(81)-(0)3-6659-8083
  • Fax.: +(81)-(0)3-6659-8093

Access

  • 6 minutes walk from exit A3 of Toei Shinjuku Line, Bakuro-yokoyama Station
  • 6 minutes walk from exit B2 of Toei Asakusa Line, Higashi-nihombashi Station
  • 5 minutes walk from exit A1 of Toei Shinjuku Line, Hamachō Station

Osaka Office

  • Sanko Bldg. 507, 1-8-2 Nishihommachi, Nishi-ku, Osaka, 550-0005 Japan.
  • Tel: +(81)-(0)6-4395-5812
  • Fax.: +(81)-(0)6-4395-5551

Access

  • 2 minutes walk from exit 27 of Yotsubashi Line, Hommachi station
  • 6 minutes walk from exit 4 of Midōsuji Line, Hommachi station
May 26

Privacy Policy

At MORE Medical Inc., we are fully aware of the importance of handling personal data. And for the complete privacy policy, we are addressing a standardized understanding of it in the office which includes all board members and employees. We are stlongly commited to protecting Private Information Protection Law and the privacy policy that we set out.

1. About collection of personal data

Persosnal data which were collected in this site is managed by MORE Medical Inc. When we collect personal data, we will indicate the purpose of use beforehand and use them within that scope.

2. About use of personal data

We will indicate the purpose of using personal data which we collected from the site of “Contact us”. And we will not use such personal data outside the scope.

3. About provision of personal data

We will not provide personal data which we collected to a third-party without your consent. However, we may provide personal data when we have to disclose them according to law.

4. About management of personal data

We will manage personal data which we collected based on our privacy policy by placing chief privacy offer.

5. About “Cookies”

On this site we may use “Cookies” considering your convenience. A “Cookies” is a small piece of information which is sent to your browser and stored on your computer’s hard drive.
“Cookies” can be used for tracking browsing behavior but “Cookies” as used by us cannot be used to discover the identity of an individual user such as name or address. You can set your browser to deny when you receive a “Cookies” but please understand that this may not enable you to print or use the service of this site.

6. About inquiry, correction , and deletion of personal data

If you wish to inquire, correct, or delete your personal data which we collected, please contact us to the address indicated in the bottom of this page. After the identity is confirmed, we will correspond based on our privacy policy.

7. About continuous improvement of the handling of personal data

We will continuosly improve our privacy policy to adapt to the social changes.

8. To use this site

Please use this site with the understanding and consent of privacy policy.

Contact info inquiries regarding privacy policy

MORE Medical Inc.
Hisamatsu Bldg. 3F, 10-10 Nihonbashi Hisamatsu-cho, Chuo-ku, Tokyo, 103-0005 Japan.
TEL: +(81)-(0)3-6659-8083
FAX: +(81)-(0)3-6659-8093

May 27

Links

  • MHLW Ministry of Health, Labour and Welfare in Japan
  • PMDA Pharmaceuticals and Medical Devices Agency in Japan
  • FDA Food and Drug Administration
  • JFMDA The Japan Federation of Medical Devices Associations
  • JETRO Japan External Trade Organization
  • GHTF The Global Harmonization Task Force
  • EC The European Commission’s Directorate General for Enterprise and Industry
  • Kobe Medical Industry Development Project The Kobe Medical Industry Development Project is the nexus of an accelerating effort to form an international cluster of medical-related industries, one of the 21st century’s key growth sectors. Research institutions and universities have already joined more than 120 companies at Port Island, where they are pursuing innovations in biomedical fields via partnerships linking industry, academia, and government.