Journal of GXP Compliance
Blueprint for the successful company
“This book provides practical strategies to maximize efficient new product development and supporting compliance structures. It addresses evolving FDA compliance requirements and new product development techniques to facilitate commercialization faster, easier, at less cost, and with less risk. The book describes a systematic and structured new product development process – discovery and preclinical through postmarket – and a regulatory compliance and quality system that will enhance business flexibility and encourage innovation.
The book is well-referenced, and provides supportive source notes and other resources. The website provides supplementary materials such as templates, to-do lists, helpful internet links, and mini-seminars that are supportive to the content of this book.
Mr. Avellanet has provided a blueprint for the successful and compliant company.”
Pharma QbD
Full of very practical tips
“Engaging and very well written … full of very practical tips on how to implement some of the sweeping changes in mindset that smart drug development and manufacturing require, all in bite-sized steps.” Read more online….
Read the following Amazon reviews to find out what readers think about Get to Market Now!
“I’m in Regulatory and this book is exactly the tool you need to easily get into compliance for the ‘new’ FDA. It provides helpful hints and checklists that will help guide your steps. It not only provides a regulatory perspective, but shows you how all functional groups need to work together to ensure compliance across the board. Highly recommended for established and new organizations!.”
You can buy Get to Market Now! through Amazon.com, Barnes & Noble, the publisher Logos Press, or your local bookstore

