Quality and compliance
Quality statement
Takara Bio USA, Inc. is committed to understanding and meeting the quality needs of all our customers. As a basic business principle, we strive to provide our customers with quality, innovative products and services. We have established a comprehensive quality assurance system that will allow us to meet our commitment to customer satisfaction. Continuous quality improvement is the responsibility of every Company employee and we build quality into everything we do.
Certifications
Takara Bio USA's quality management system has received a certification specific for medical devices and related services under ISO 13485:2016.
GMP manufacturing sites
Takara Bio's GMP production facility in Kusatsu, Japan, hosts our contract manufacturing organization (CMO) services, and is the manufacturing site for our GMP-grade products, which include Takara Taq and Titanium DNA polymerases as well as our xeno-free stem cell culture medium. In 2018, a second GMP facility located in Gothenburg, Sweden, was granted a manufacturing license by the Medical Products Agency (the Swedish national authority) for clinical-grade human embryonic stem cell line derivation and banking.
Takara Bio USA, Inc.
United States/Canada: +1.800.662.2566 • Asia Pacific: +1.650.919.7300 • Europe: +33.(0)1.3904.6880 • Japan: +81.(0)77.565.6999
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