This is a course for people whose native language is other than English and who must write documents in support of therapeutic product development or regulatory submissions. This course is valuable for pharmaceutical, medical device, and biotech professionals in drug discovery, product development, quality assurance, clinical testing, information technology, and regulatory affairs who have some understanding of English, but wish to refine their writing skills. It is also helpful for native-born writers who want to better understand the English language and how to control it.