Writing for the Biopharmaceutical Regulatory Reader just published!

This book provides guidance for beginning and advanced authors, as well as reviewers, of biopharmaceutical documentation. Available in Kindle and Paperback editions.

We explore in this book 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?  

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Best thing I've read in 25 years of medical/regulatory writing. It isn't academic. It isn't esoteric. It is the most practical and useful guide to bring professional medical writing into the 21st century when writing for regulatory readers at FDA, EMA, and drug approval agencies worldwide who are using 21st century tools to review applications for drug approvals. ~Amazon Customer Review

McCulley/Cuppan provides customized training, consulting, and project support services designed to improve the planning, authoring, and finalization of complex technical, scientific, and regulatory documentation.

Our goal is to help clients execute mission-critical documents so as to launch research and complete development work faster and more efficiently with improved returns on their money, time, and resources.

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Tailored Training

McCulley/Cuppan's highly acclaimed skills development workshops focus on all aspects of the document development process, from
pre-writing planning, to authoring, to team revising, and on to reviewing.

Each workshop is tailored to the needs of the
participants so that new knowledge and skills are immediately applicable to their work place. Our workshops are intimate because we use document samples drawn from the company as the basis for the discussions and exercises occurring in the workshop session.

We have tailored workshops to fit corporate and cultural demands in US/Canada; Europe; Middle East; India; and China.

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Consulting

McCulley/Cuppan offers resources and tools to facilitate your document development projects as well as strategic review.

These consulting services can help you analyze the effectiveness of your current documentation work practices, optimize ways of working to provide better output, or improve the usability of your document templates.

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Quality Assessment

Through our document quality assessments, McCulley/Cuppan provides analysis of the communication quality of your documents and in-turn, the effectiveness of a team in terms of how their approaches to planning, authoring and reviewing impacted the final version of a document.

High quality scientific and technical documents can be characterized as issue-driven in their design. We use our assessments to teach groups the key to success for teams: to anticipate what readers likely perceive as issues and then effectively design responses to those issues in the document.

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Writing for the Biopharmaceutical Regulatory Reader: buy your Kindle or Paperback copy today!

...Don’t let the specific title fool you; while geared towards a biopharmaceutical audience, this text also has plenty of relevance for multiple technical audiences...

Rooted in research insights regarding the psychology of decision-making, reading behaviors, and complex information design, this text offers clear, logical, and practical guidance to allow writers to successfully meet the needs of multiple purposes and audiences. Within each chapter Cuppan and Bernhardt draw from their extensive experience consulting in the biopharmaceutical industry to provide successful writing strategies. These strategies span from careful analysis of audience and situation of use to macro-level concepts of information design, all the way through micro elements such as sentence-level style. Throughout Writing for the Biopharmaceutical Regulatory Reader, the authors include multiple exemplary and faulty examples to effectively illustrate each of the concepts they present. ~ Amazon Customer Review

Why Greg and Stephen wrote the book: