Regulatory Guidance / Guideline List Now Available
A list of FDA guidance and EMA guideline associated with CMC development activities for Biopharmaceuticals is now available in our Web site page. A list of Japanese guidance notification specific to Biologics development is also available.
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Seminar Information Being Organized by BCRET; A Basis of Process Development for Biopharmaceuticals
Regular seminars, in which our company representative is invited as a speaker, are organized and held by BCRET. A typical topic entitled is “A Basis of Process Development for Biopharmaceuticals“. Please Refer to Seminar/Event page for details (Only Japanese available).
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June 2020, List of Japanese Notifications Available
A list of Japanese Notifications needed to consider Biopharmaceutical development is now available in Publication Page. (Only Japanese language version)
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May 2020, Recent Activities at BioStrad Lab LLC
Since July 2019, BioStrad Lab has been offering consultation and supporting services on CMC development activities of biopharmaceuticals in Japan. Even though the services are still in commencement phase, we have provided our advice and supporting values to our customers based on our experiences and knowledges. The examples include but are not limited to technical and regulatory advices on process and methods transfer from foreign countries to Japanese locations, document review and regulatory supports for CTN/BLA filing to Japanese agency, proposals on biosimilar monoclonal antibody development strategy being introduced to Japanese market, CMC development supports associated with clinical studies in Japan, and precise review and translation of technical, scientific and/or regulatory documents to Japanese language, etc.
As availabilities of highly qualified Biologics CMC consultants are very limited in Japan, there would be a big advantage in choosing BioStrad Lab when considering introduction of your products into Japanese pharmaceutical market. In spite of significant impact of recent COVID-19 outbreak, we will keep supporting your CMC development activities in a timely manner. If you need anything to ask on biopharmaceutical consultation and regulatory supporting activities in Japan, please feel free to contact us.
Toshiyuki Suzawa, Ph.D., President & CEO, BioStrad Lab LLC
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July 1st, 2019, Web site of BioStradLab just released
BioStrad Lab has got started the consulting businesses on product development and regulatory support on CMC activities of biopharmaceuticals in Japan. Currently, the services are limited due to commencement phase. If you need something to ask on biopharmaceutical consultation activities in Japan, please feel free to contact us.
