Gough is a consultant to the pharmaceutical, biotech, and medical device industries, has taught English at the university level, and is a faculty member of professional training organizations. She provides an overview of the regulated environments in which companies develop, manufacture, and distribute therapeutic products. The text is designed to help writers understand the "why" of what they must write and current industry standards for good documentation; to provide effective examples from a range of documents; and to provide in-depth explanation of grammar and punctuation conventions. For the second edition the text has been updated and expanded throughout; specific revisions are not stated.