Consultation on CMC Development of Biopharmaceuticals
BioStrad Lab offers consultation on Process Development (Cell Line, Cell Culture, Purification, Formulation), analytical method development, development strategies, CMO/CDMO/CRO utilization, technology transfer, GMP manufacturing / management, due diligence support, etc.
Review, Writing Support and Translation of CMC Documents for Biopharmaceuticals
BioStrad Lab offers review, documentation support and translation (between Japanese and English) of CMC documents including Investigator’s brochure, IND, IMPD, BLA, MAA, PACMP, Comparability Protocol, and standard operating procedure, batch record, etc. In Japanese applications, precise and strategic translations are the key to successful approaches toward approvals. This is one of the strongest advantages in collaborating with BioStrad Lab.
CMC Development Support for Biopharmaceutical Seeds Discovered Through Basic / Discovery Researches
BioStrad Lab offers connections between discovery research and development for MONOZUKURI by supporting research activities on Biopharmaceutical seeds discovered in organizations such as companies and universities having little experiences in CMC development.
Seminars and Events
BioStrad Lab offers some seminars and events on Biopharmaceutical CMC development in Japan. The contents can be arranged according to your needs/requests.
Publications and Repotrs on CMC Development of Biopharmaceuticals
BioStrad Lab provides some information through our unique reports and publications on CMC development of Biopharmaceuticals in Japan. (The materials are in preparation to release.)
Depending on your needs and requests, BioStrad Lab offers various services on Biopharmaceuticals CMC development activities. BioStrad Lab also seeking collaborations with potential partners in the world. If you have any questions / requests, please feel free to contact us.