Corgenix Contract Services is one of the fastest-growing branches of our company. We collaborate with other IVD companies, technology start-ups, clinical laboratories, CROs, and pharmaceutical companies, all of which are in need of a partner organization with the infrastructure and expertise in the development, manufacturing, and commercialization of Research Use Only (RUO), Investigational Use Only (IUO) and In Vitro Diagnostic (IVD) products.
We have recently expanded our capabilities in Enabling Diagnostics and Companion Diagnostics in order to benefit our pharmaceutical company partners. This augmentation assists in the timely development and advancement of tests that reliably detect mutations in proteins and antibodies, resulting in more effective, personalized treatment. Alternatively, our role might be supporting our pharmaceutical partner in the development or improvement of RUO or IUO products to advance their science, global recognition, or clinical studies, and if appropriate, move to IVD to supporting their global commercialization effort.
Our Contract Services capabilities include:
- Product development using numerous diagnostic platforms
- Contract manufacturing of test products and controls/calibrators
- Private labeling
- Regulatory management, including preparing and filing submissions to the FDA and managing CE marking
- Warehousing and fulfillment
- Distribution and commercialization
Corgenix Contract Services has been providing solutions for over twenty years, applying our critical competencies within the highly regulated medical device industry. We are committed to providing innovative and quality medical products to meet our partners’ needs, and can respond quickly, dedicating our best minds to their projects. Contact us to learn more about our capabilities.