Japan
Expert on Human Drugs & Biologics and Medical Devices
CoreMed Contact: Masami Tamura, Executive Vice President and COO Osaka Office Tsunenari Bldg., 2-1-21 , Kitahama Chuo-ku, Osaka 541-0041 Japan Phone: +81 (0)6 6221 1352 Fax: +81 (0)6 6221 1357 Email: mtamura@coremed.co.jp Web: http://www.coremed.co.jp |
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Tokyo Office KN Nihonbashi Bldg. 4-8-17, Nihonbashi Honcho, Chuo-ku, Tokyo 103-0023 Japan Phone: +81-3-5205-2757 Fax: +81-3-5205-2758
CoreMed Corporation, a Strategic Regulatory and Drug Development consulting organization, was founded in March 1998 in Osaka, Japan. CoreMed dedicates itself to helping companies develop and register their products efficiently and expeditiously with navigating them through the regulatory approval process in Japan. We have been providing practical and strategic supports for designing regulatory/development strategies, analyzing the gap between data and regulatory requirements. Over the years CoreMed has been growing and is now the largest, unique and the most reliable regulatory consulting company in Japan. CoreMed also helps global development including Europe, USA and Asia through its affiliates and alliance partners. Affiliates: CoreMed America LLC, in the USA and Regulatorix Asia, Ltd. in China.
Services are: - Strategic regulatory advice
- Gap analysis, Feasibility study and R&D due diligence
- Consultation (Scientific Advice) meetings with the regulatory authorities
- Orphan drug/device designation application
- Application for clinical studies
- Submission for marketing approval
- Medical/Technical writing
- Master File Registration
- Foreign Manufacturer Accreditation
- National Health Insurance Pricing
- Project management
- Regulatory intelligence
CoreMed is a member of the Osaka Pharmaceutical Manufactures Association. |