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