Quality Services

MassBiologics is committed to maintaining the highest standards of quality in each cGMP project that we undertake.  Quality systems are an integral part of our cGMP operations and serve to ensure that manufacturing meets all appropriate regulatory standards.  As a manufacturer of FDA licensed product our quality systems are regularly scrutinized during routine FDA inspections as well as audits by our clients and strategic partners.    MassBiologics is licensed as a multiproduct biologics manufacturing facility and we are experienced at managing licensed and investigational products in the same manufacturing spaces and systems.  While our quality system encompasses a range of clinical phase-appropriate policies and standards, MassBiologics has a single unified quality system and we guarantee that we will bring the same standards, care and attention to detail to your project that we have successfully applied to our own licensed and investigational products.  We embrace a policy of continuous improvement and the recommendations we receive from auditors are carefully considered and implemented whenever practical.  Quality Audits by potential customers are encouraged.