Speed New Drug and Medical Device Time to Market with Advice in New Book by Cerulean's Managing Director

Williamsburg, VA, February 19, 2010 --(PR.com)-- More than 83% of new medicines never make it to market, wasting billions of dollars, decades of research and development, and millions of patients around the world. In the new book, Get to Market Now! Turn FDA Compliance into a Competitive Edge, author John Avellanet provides practical strategies to help executives tap into the secrets of new product development and the FDA quality and regulatory compliance structures to match. The book teaches readers how to take advantage of evolving FDA compliance requirements and cutting-edge new product development techniques to bring new medicines to market faster, easier, for less cost and less risk.

At the heart of the book is a systemic, structured new medicinal product development process – from discovery and preclinical through the postmarket stages – and a blueprint for a regulatory compliance and quality system designed to enhance business flexibility and encourage innovation.

Based on years of work in his own career, plus advising clients around the world, author John Avellanet walks readers through how to:

- Build safety, efficacy, and patient needs into a developing new medicine from day one
- Set up a cost-effective FDA quality system to maximize flexibility
- Get the right suppliers, professional services, and other help at the right times
- Use technology and innovative techniques to minimize risk
- Protect the firm from regulatory enforcement

The book is packed with “to-do” lists and full of links to online resources, templates, checklists, downloads, and other valuable material.

Get to Market Now! will be published May 1, 2010, but is available for pre-order today through Barnes & Noble and other fine booksellers. Journalists and editors who would like a complimentary review copy need only contact the publisher, Logos Press (www.logos-press.com).

Mr. Avellanet has gained tremendous acclaim on his speeches, workshops and teleconferences for corporate clients and conference venues around the world. Enthusiastic testimonials from attendees cover his speaking page on his website. Conference organizers and program directors repeatedly note that he gets the highest evaluations of any of their speakers.

John Avellanet is the author of more than 100 articles, is the FDA compliance columnist for several international industry journals, and is the founder of the private compliance advisory firm, Cerulean Associates LLC. Every month, he publishes the regulatory intelligence and quality systems advice newsletter, SmarterCompliance™. Learn more about Mr. Avellanet on his blog, www.ComplianceZen.com, or through his company’s website at www.ceruleanllc.com.

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