Alison Bamberg Email
Program Director | Companion Diagnostics | Medical Devices | Biotechnology . Corgenix
Broomfield, CO
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Corgenix, founded in 1990, is a medical diagnostics company based in Broomfield, Colorado. 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, meaning we will develop tests on any platform that meets the technical, clinical and commercial requirements of our clients and their customers. 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, clinical trial testing or contract clinical testing services, we are here to serve. 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? Please contact us to see how we can support your business strategy!Corgenix Address
11575 Main StreetBroomfield, CO
United States