Writing for the Biopharmaceutical Regulatory Reader

by Gregory P Cuppan, Stephen A Bernhardt

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.

201 pages, Paperback

Published February 20, 2022