Avioq
Mike Cronin has a diverse work experience spanning over several decades. Mike began their career as a Research Scientist at Nuclear Medical Laboratories (Warner Lambert) in 1982 and held this position until 1985. Following this, they joined Organon Teknika in 1986 as a Product Manager, where they introduced and developed the commercial awareness of the Nucleic Acid Diagnostics division in North America. Cronin also served as a liaison between the International Business Area in the Netherlands and the North American Marketing and Sales teams. At Organon Teknika, they created and directed the NASBA Marketing Group to support sales. In 2001, Cronin joined BioMerieux as a Marketing Manager in the Clinical Marketing Department. Mike directed activities related to market penetration of FDA approved HIV viral load assay and integration of rapid urine bacteria screening capabilities into the overall company strategy. Cronin then transitioned to the role of Director of Business Development at Avioq in 2009.
Mike Cronin attended Cistercian Preparatory School from 1969 to 1973, where they obtained a Diploma. Mike then pursued their undergraduate studies at Texas A&M University from 1973 to 1977, earning a Bachelor of Science (BS) degree in Biomedical Science. Following this, they attended the University of Georgia from 1980 to 1982, obtaining a Master of Science (MS) degree in Veterinary Physiology & Pharmacology.
Avioq
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Avioq is an in vitro diagnostic medical device manufacturer and a contract development, contract manufacturing organization. Based in Research Triangle Park, North Carolina Avioq has a FDA licensed manufacturing facility and large, modern R&D laboratories. Our products include an FDA licensed HTLV-I/II assay for screening serum and plasma from blood donor and cadaveric samples, which also has CE marking and Health Canada approval. The Avioq HIV-1 assay is the only product with FDA approved claims for testing serum, plasma, dried blood spots, and oral fluid specimens. The FDA approved HIV Profile™ assay is an enzyme-linked immunosorbent assay (ELISA) for confirmation and differentiation of individual antibodies directed to various gene products of HIV-1 (Group M & Group O) and HIV-2 in human serum or plasma. It is intended as an additional, more specific test to confirm the presence of antibodies in specimens repeatedly reactive in diagnostic procedures. Why work with Avioq for your next CDMO project? Instead of using consultants who talk about the regulatory process we actually live it. We develop and manufacture our own FDA and CE Mark products to the highest standards. The manufacturing facility is FDA (BLA) licensed and ISO 13485:2106 certified. The facility has been inspected numerous times by FDA and ISO, as well as by external partners. Need a quick answer? We can help you with: ● Exploratory research ● Proof of concept projects ● Feasibility studies ● Research lots If you entrust your project to Avioq, we will focus on getting your product through our mature Quality System, approvable by Regulatory Authorities, manufactured and to market as quickly as possible. Our team will guide you past the regulatory delays and pitfalls. Our R&D, quality and manufacturing teams have successfully designed and developed numerous medical diagnostic products during the past 25 years.