The core of Corgenix’s business is partnering to develop Companion Diagnostics that enable Personalized Medicine and to provide Contract Manufacturing services to the Diagnostics and Biotechnology industries. Our services include:
- Product development
- Regulatory management including preparing and filing submissions to the FDA and global Regulatory Authorities
- Clinical trial support
- Private labeling
- Warehousing and fulfillment
- Distribution and commercialization
Our product development and regulatory expertise, strong quality system, solid infrastructure, expert staff and state of the art manufacturing facility have attracted partners from all over the world. For over twenty years we have provided contract services to large and small medical companies, universities, research institutions and government agencies.
Corgenix offers critical competencies within a highly regulated industry. We are committed to providing innovative and quality medical products to meet the needs of the ever-changing healthcare field and believe our vision and commitment places our company at the forefront to do so. We can develop and support products utilizing numerous diagnostic delivery platforms.
Our operation in Colorado is FDA registered as well as certified to ISO 13485 and fully compliant with EU provisions for CE mark products and the Canadian Medical Device Regulation.