Writing for the Biopharmaceutical Regulatory Reader Second Edition just published!
|
This edition offers expanded guidance for writers and reviewers of biopharmaceutical documentation with practical strategies to improve regulatory writing across reports, briefing books, regulatory responses, and drug marketing applications. We have added new chapters on lean writing principles and writing actions—critical tools for ensuring that regulatory communication is efficient, clear, and persuasive.
Regulatory writing is evolving, and this edition addresses the growing need for efficiency and strategic clarity in documentation. Regulatory writers face challenges in communicating complex scientific data, aligning document content with agency expectations, and ensuring that key messages are immediately clear and actionable. Whether crafting a pivotal study summary or responding to regulatory queries, this book helps you anticipate the regulatory reader’s needs and optimize communication. |
Available on Kindle or as a paperback from Amazon
|
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 on the First Edition
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.
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.
Tailored TrainingMcCulley/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. |
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. |
Quality AssessmentThrough 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. |
