Books and Published Works

Writing for the Biopharmaceutical Regulatory Reader just published!

This book provides guidance for beginning and advanced authors, as well as reviewers, of biopharmaceutical documentation.

Written by Greg Cuppan and Stephen Bernhardt, the book is intended for those who wish to improve their ability to contribute to high-quality regulatory writing. Whether it is a briefing book, responses to regulatory inquiries, or marketing authorization packages, this book will help you think more productively about regulatory readers, how they use what you have written, and how to accomplish more within a paragraph, section, an entire document, or a complex dossier.  
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Over the past 30 years, we have had the opportunity to formally evaluate how readers engage with submission documents. These interactions have helped us to refine our understanding of the decision-making behavior of the regulatory reader. 
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In this book, we explore the kinds of questions many writers face on a routine basis:  

• How can I best accomplish my purposes? What do I want my readers to know or to do? 
• How do I align writing with anticipated outcomes?  
• How do I write for an expert regulatory reader? How will they use my document? 
• What are their known concerns? How much detail must I share for them to understand our position or interpretation?  
• How do I keep documents relatively short, focused, and useful?  

This book is filled with valuable context and practical, immediately applicable writing advice for medical writers. I’ve been in the industry almost 10 years and am always looking for ways to sharpen my messaging skills. Bernhardt and Cuppan give a deep dive into the reviewer mindset of document use, walk you through overarching organization principals, and end with a handy sentence-level primer on good scientific writing. Best of all are the numerous examples and commentary on each one, turning abstract concepts into clear demonstrations. If you’re a medical writer, definitely pick up this book! ~ Amazon Customer Review

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Learn More:

Why did we create the book?
"The fact is that people in industrial settings often don't get help with their writing...There's a gap between a college classroom and a work setting."

Document Design
"Information design is essential to the success of all regulatory writing projects...We have to create a document the reader can use."

What makes regulatory writing different from other scientific writing?

What makes this book different?

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Coming Soon:

Greg and Stephen are working on a book for chemists, specifically those who work to assure quality in CMC (chemistry, manufacturing, control).