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

   

 

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.