Quality Systems
The Biomanufacturing Center in Hopkinton, MA now offers an established Quality System to support production of early phase bulk drug and diagnostic products. Our systems are compliant to applicable portions of 21CFR Parts 210, 211, 600, 610, and 820 as well as ISO 13485. Click to view our ISO 13485:2016 certification.
The Development and Manufacturing Center in Hayward, CA now offers an established Quality System to support production of support materials of Analyte-Specific Reagents (ASR). Our systems are compliant to applicable portions of 21CFR Parts 820 as well as ISO 9001:2015.
Close collaboration exists between our analytical development and our QC teams, all operating under QA and OPS oversight to further streamline feasibility/development and final qualification of custom methods. Here you see a standard analytics package for an antibody or protein therapeutic.
- Approved Quality Manual
- Experienced Quality Assurance Team
- Customized creation of client records and specifications
- Independent QA batch review and disposition
- Established approved supplier list
Click to view our ISO 13485:2016 certification.
Our systems are compliant to applicable portions of 21CFR Parts 820 as well as ISO 9001:2015.