Writing for the Biopharmaceutical Regulatory Reader

This book provides guidance for beginning and advanced authors, as well as document reviewers, of biopharmaceutical documentation. Our book is intended for those who wish to improve their ability to contribute to high-quality regulatory writing. Whether it is a briefing book, protocol, study report, responses to regulatory inquiries, or marketing authorization packages, this book will help you think more productively about how regulatory readers interact with documents, how they use what you have written, and how to accomplish more within a paragraph, section, an entire document, or a complex dossier.We have kept the content simple and practical with an extensive collection of exemplar writing. Our examples are modeled on actual documents we have assessed over the years. We also present what we consider a bad example and a revision that works better, according to our standards.FeaturesLooks closely at the critical authoring concepts of audience, purpose, and situation of useDiscusses how to effectively organize information for the busy, highly selective professional readerExplores the roles paragraphs must fulfill to create effective discussions, analyses, and argumentsFocuses on improving and refining writing style within the context of authoring documents in the biopharmaceutical industry Read more