Sandy Goldman

Avioq

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.