Figure バイオテクノロジー

– CMC Development Support and Consultation on Biopharmaceuticals in Japan –

BioStrad Lab offers CMC (Chemistry, Manufacturing and Controls) support and consultation in the field of Biopharmaceuticals development such as monoclonal antibodies, proteins, peptides and biosimilar products in Japan.  There have been a very limited number of companies and consultants in Japan that can provide CMC development supports with high qualities for clinical trials, market applications and post marketed lifecycle management on Biopharmaceutical products.  The regulatory circumstances of Biopharmaceutical development in Japan appears very unique due to distinct regulations / requirements as compared to those in eastern countries such as US and EU.  Based upon a lot of experiences in CMC development of Biopharmaceuticals for more than 20 years, BioStrad Lab will provide opportunities for the companies and organizations that intend to file clinical trial applications as well as marketing authorization applications to support and collaborate their CMC development activities in Japan.