CoreMed Contact: Masami Tamura Tsunenari Bldg., 2-1-21 , Kitahama Chuo-ku, Osaka 541-0041 Japan Tel: +81 (0)6 6221 1352 Fax: +81 (0)6 6221 1357 E-mail: 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 Tel: +81-3-5205-2757 Fax: +81-3-5205-2758

CoreMed is an established Strategic Regulatory consulting company founded in 1998 in Japan and has been providing pharmaceutical companies with unparalleled services in drug development in Japan. CoreMed dedicates ourselves to helping pharmaceutical companies develop their products efficiently and expeditiously with navigating them through the regulatory approval process in Japan. CoreMed’s experts in Regulatory affairs, CMC, Nonclinical and Clinical are passionately supporting pharmaceutical companies to bring their products to launch by designing the most appropriate development strategy.

Services are:

• Gap Analysis and Feasibility Study
• R&D Due Diligence
• Review and Establish Development Strategy
• Regulatory Submissions- Orphan drugs, CTN, NDA, DMF
• Liaison with Regulatory Authorities, MHLW/PMDA
• Clinical and Nonclinical Study Management

CoreMed also helps global development including the USA and Europe through its office in Washington DC and alliance partners in the UK.