Avioq, a trusted clinical diagnostics company, has developed a broad line of in-vitro diagnostic assays for the clinical lab. With this experience, we offer extensive contract development and manufacturing services.
Our manufacturing facility is a FDA licensed facility for both BLA and PMA products as well as an ISO 13485:2016 certified facility.
Kitting Finished Product
Pouch Sealing
Custom Packaging
Regulated Kit Labeling
Hand Assembly
Sourcing of Components
Lot Product Management
Quality Control
Domestic and International
Pallet Shipments
Warehousing
Temperature Monitoring
Bio-manufacturing and analytical capabilities include recombinant protein production either in mammalian or bacterial cells, monoclonal antibodies produced in hybridomas, and viral lysates/virus produced from large-scale cell cultures.
Avioq’s Design Control and Quality Systems are fully developed. Our facility has been inspected numerous times by FDA and ISO, as well as by external partners.
Avioq has met all FDA 21 CFR Part 820 and ISO 13485:2016 requirements for document and purchasing controls, complaint handling, CAPA, non-conformances, design/production/process controls, quality audits, risk management and training.