English

Bio CMC Inc. was established in 2014 as a consulting company for the pharmaceutical companies.
We promise to provide satisfactory services to customers in various fields related to drug development and registration, and solve various problems for customers.
The company's strength is to have most experienced talents in the development and registration of biological products.

Company Profile

医療申請までを総合的にサポート 医薬品開発に特化した専門集団 書類作成のノウハウ クライアントの立場でニーズを実現 開発の短縮化費用の削減

Company Profile

Company name: BioCMC Inc.

Founded: April 2014

President: Toshihiro Ishii (M.D.,Ph.D.)

Location: 14-13, Nakayama 4-Chome, Ichigawa-City, Chiba 272-0813, Japan

Phone: +81-80-3124-1214

Fax: +81-47-420-8525

Department: Regulatory; Drug registration; GMP Supporting; Drug Master File; Non-Clinical & Clinical

Main Business
The following consulting business related to pharmaceutical development

  • Regulatory Affairs (Development strategy, Registration strategy)
  • CMC gap analyses and CTD preparation
  • Submission of Japanese Accepted Name for Pharmaceutical (JAN)
  • Certification of orphan drug
  • Registration of drug master file (DMF) and in-country caretaker
  • Foreign factory certification
  • GMP submission/Discrepancy survey (real production/testing methods vs approval application form).
  • Overseas Pharmaceutical Affairs Survey
  • Critical trial supporting (CMC part)

Please contact US

Phone: +81 80-3124-1214

バイオCMC株式会社 Bio CMC INC.

2014年4月設立

千葉県市川市中山4-14-13

TEL 080-3124-1214(担当者直通) 
FAX 047-420-8525