Quality Systems

LakePharma is excited to add GMP production and testing to its menu of services!  The microBiomanufacturing 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 here 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. 

    • Approved Quality Manual
    • Experienced Quality Assurance Team
    • Customized creation of client records and specifications
    • Independent QA batch review and disposition
    • Established approved supplier list