Assay Development Services
Our Process
When you use our proven quality system and development process, your IVD project will benefit from the fastest, most streamlined path through manufacture, approval, and to market.
Why Choose Avioq for your IVD Assay Development Project?
We have a highly experienced team of scientists, project managers, regulatory and quality staff that have a long history of successful implementation of complex IVD development projects. By using a nimble cross-functional team approach, we partner with you to complete your IVD project with speed, accuracy and the quality necessary for FDA and other international regulatory agency approvals.
Custom Assay Development
Avioq’s research scientists are experts in ELISA assay development and can assist clients based on their requirements. Working side by side with you, Avioq provides efficiencies with shorter timelines to accelerate IVD product development and commercialization.
Our facility is fully equipped to perform the conjugation of purified antigens or monoclonal antibodies to a marker, e.g., horseradish peroxidase (HRP), alkaline phosphatase (AP), avidin or biotin.
Design and Development Phases
R&D
Our R&D facility is fully equipped with modern laboratory spaces. The general laboratory space is divided into dedicated spaces for work in immunology and immunochemistry, microbiology, cell culture, and manufacturing process development performed in our pilot production facility.
Our R&D scientific team has designed and developed numerous medical diagnostic products during the past 25 years. As a result, our R&D team, along with our teams in manufacturing, quality assurance and regulatory, have extensive experience in all phases of IVD product development, starting from raw material development and finishing with an FDA approved and/or CE marked IVD.
Quality Systems
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. Avioq has proven processes with the successful commercialization of our own portfolio of in vitro diagnostics kits.
Avioq applies our scientific, manufacturing and quality expertise to provide start-up companies or research institutions with immediate services and capabilities to take your assay/test to the next level of use and/or commercialization.