Radient Pharmaceuticals Manufacturing Facilities

The Radient Pharmaceuticals manufacturing facility, which is located in Tustin, California, maintains a device manufacturing license issued by the State of California, Department of Health Services, Food and Drug Branch and is an FDA/GMP approved manufacturing facility. The Onko-Sure DR-70® (FDP) test is also manufactured and distributed at the Radient Pharmaceuticals (Tustin, California) manufacturing headquarters. Radient Pharmaceuticals manufactures the Onko-Sure DR-70® (FDP) test in compliance with the USFDA GMP requirements. Radient Pharmaceuticals has maintained an effective and suitable quality management system that was established to ensure company compliance to the USFDA CFR 21 Part 820, the Canadian Medical Device Regulations (CMDR) and certification to ISO 13485, which is the internationally recognized quality management standard for medical devices. In addition, Radient Pharmaceuticals has obtained certification for CE marking of the Onko-Sure DR-70® (FDP) to market and distribute the product to countries in the European Union. Radient Health Pharmaceuticals is also a supplier of bulk reagents and tests to many diagnostic companies and/or large volume distributors who require private label and/or OEM packaging.

Radient Pharmaceuticals Quality Policy Statement

“Radient Health Pharmaceuticals tradition to quality is built into our products. We are committed to providing quality products that meet the needs of our customers. Customer satisfaction is the key concern. Operations will strive to meet regulatory requirements as well as addressing the ever-changing needs of our customer base. Employee training, education, and teamwork enhance continuous improvement and innovation to demonstrate our commitment to providing quality products and services.”

Radient Pharmaceuticals Distribution Relationships

Radient Pharmaceuticals has established and maintains direct distribution relationships with distributors and/or dealers which allow the Onko-Sure DR-70® (FDP) kit to be marketed and available worldwide. Currently, the Onko-Sure DR-70® (FDP) test is available in the U.S., Germany, Canada, U.K., Korea, Taiwan and India. Radient Pharmaceuticals is in the process of expanding its market to additional countries including China, Latin America, the Middle East, Australia and several counties in Asia-pacific and in the European Union.