Vice President, Regulatory Affairs
Matthew is a GxP regulatory, clinical, and quality assurance professional with 30 years of experience providing regulatory and quality assurance services for healthcare companies, including medical device, IVD, and pharmaceutical companies. He is knowledgeable in both medical device and drug development regulations, including Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and Good Manufacturing Practice (GMP) regulations.
Matthew has direct experience with Class III IVDs as well the successful implementation of an LDT from initial design validation to successful processing of samples for multiple solid tumor cancer types in the US and India. Matthew has developed and advanced innovative technologies from surgical robotics to molecular diagnostics, biologics, blood products, and all classes of medical devices, both therapeutics and IVDs.
He has developed, executed, and managed global quality assurance programs at various healthcare organizations and has experience in assessing conduct compliance of clinical research/development activities to applicable regulations and guidelines, scientific protocols, and SOPs. He has also prepared and managed several successful global product registrations including PMA, 510(k), NDA, and BLA submissions and their international equivalents.
To learn more about Premier Consulting’s regulatory services & support, click here.