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 21 CFR Parts 210, 211, 600, 610 and 820 as well as ISO 13485. Click here to view our ISO 13485:2016 certification.

       - Approved Quality Manual

       - Experienced Quality Assurance Team

       - Customized creation of client records and specifications

       - Independent QA batch review and disposition

       - Established approved supplier list

Please contact LakePharma at inquiries@lakepharma.com for more information.

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