ABSTRACT
The pharmaceutical industry of today is experiencing unprecedented challenges and rapid transformation. For the purposes of this text, the pharmaceutical industry includes the producers of pharmaceutical products and their chain of service providers, including professional consultants, material and equipment suppliers, contract manufacturers, and any other entities that are involved in delivering regulated medicines (e.g., drug substance and products, whether chemically or biologically based, supplied as tablets, liquids, or injectables, or delivered by a medical device as defined by the U.S. Food and Drug Administration [FDA]).
