Drug development defines the entire process of bringing a new drug to the market. It includes drug discovery from basic research, pre-clinical research within microorganisms or animals, clinical studies on humans, FDA filing and reviewing, and eventually achievement of FDA marketing approval. Read more

Medical Devices

The development and manufacture of medical devices under a controlled environment is essential to assure that the device will be safe and effective in accordance with its intended use. Medical devices are regulated based upon a classification system that evaluates the complexity and the risk posed by the product and the level of control needed to adequately assure safety. Read more

In vitro Diagnostics (IVD)

The FDA regulates IVD devices in accordance with the device provisions of the US Federal Food, Drug and Cosmetic Act (FDCA). Like other devices, IVDs are classified into one of three classifications that govern the types of regulation to which they are subject. Read more