Companion Diagnostics
Avioq is an experienced leader in companion diagnostics, ELISA assay development and has a long history of successful IVD manufacturing in the United States.
We have the regulatory experience and quality systems in place to assist you in obtaining product approval from the FDA, CE Mark and Health Canada agencies.
Our facility has been inspected numerous times by FDA and ISO, as well as by external partners.
Avioq’s streamlined, proven assay development system enables us to test and optimize your prototype to have it ready for clinical trials in the fastest timeframe. And our team can guide you past the regulatory delays and pitfalls.
Complete Companion Diagnostic Services and Support
- Feasibility studies
- Exploratory research and research lots
- Assay development and validation
- Mature Quality System
- Regulatory Expertise
Partner with a company that is flexible and able to move quickly to meet your assay development requirements and project timelines. Choose Avioq as your guide and partner for Companion Diagnostics Services to custom develop and commercialize your CDx project.
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.