Corgenix, founded in 1990, is a medical diagnostics company based in Broomfield, Colorado. Corgenix is part of the Sebia Group. We are a full service partner to the Diagnostics and Pharmaceutical industry, offering a broad and unique array of products and capabilities. We are experts in the development, tech transfer, registration, manufacturing and commercialization of specialty diagnostics tests.
For contract development, what makes us different from others is that we are platform agnostic. What this means is that we will develop tests on any platform, depending on the requirements of our client. We will develop on any platform that meets the technical, clinical and commercial requirements of your customer. In addition, we pride ourselves on our project management skills and our robust quality management system. All of our development projects are conducted under strict design controls, with a focus on meeting promised timelines and budgets. We also help our partners with FDA and international registration processes and commercialization. In addition, we provide assay validation services, reproducibility and bridging studies.
For contract manufacturing, quality is the key differentiator. We are ISO-13485:2016, an FDA registered facility and GMP compliant. We produce private label tests as well as our own product lines in our Broomfield facility.
Corgenix also has an on-site CAP/CLIA certified laboratory. Whether you need support for research or clinical trial testing or routine clinical testing services, we are here to help.
Above all, we believe in clear communication and transparency. We take a cross-functional team approach to our projects, fully engaging with our clients throughout the project. What do you need? Let’s see how we can help! Please contact us (anchor tag to contact info at bottom of page) to see how we can support your business strategy!
Sebia is a specialized In Vitro Diagnostic player and the world’s leading provider of clinical protein electrophoresis equipment and reagents for the screening and monitoring of various diseases, primarily in the areas of Oncology (Multiple Myeloma), Diabetes, Hemoglobinopathy and other rare pathologies. Headquartered in the South of Paris (France), We set high standards in making continuous advances in CE technology, scientific excellence and manufacturing capabilities, providing Sebia the possibility to pursue diagnostic solutions with an exciting pipeline of new tests and automated equipment.
Learn more about Sebia: www.sebia.com