FDA Advice for 2009 Published by Lean Compliance Expert and Cerulean Associates

Williamsburg, VA, January 18, 2009 --(PR.com)-- In his annual report analyzing and summarizing expected FDA initiatives for the new year, John Avellanet, managing director of Cerulean Associates LLC, discusses the increased enforcement scrutiny, regulatory changes, and guidance issuance that he expects to unfold over the next twelve months. Nine of his analyses have been published in Pharmaceutical Magazine’s January issue in the article, “FDA Tea Leaves – Nine Things to Expect in 2009.” Each prediction comes with a set of expert FDA advice and recommendations for companies to consider adopting.

Mr. Avellanet will expand upon his analyses and recommendations dealing with FDA enforcement in his upcoming teleconference on January 28th, “Bulletproof Yourself against FDA Enforcement in 2009.”

Subscribers to Mr. Avellanet’s monthly regulatory intelligence newsletter, SmarterCompliance™, received the 11-page report, “2009: A Look Ahead,” with 45 specific recommendations in December of last year. Under a special agreement with Pharmaceutical Magazine, Mr. Avellanet selected nine of the analyses and advice to publish in the magazine’s January issue.

Mr. Avellanet has nearly two decades of experience with regulatory compliance, research and development product commercialization and quality systems, particularly in the areas of preclinical, quality by design, Part 11 and Annex 11 compliance, and preventing intellectual property theft by insiders and partners. Mr. Avellanet serves as a compliance columnist for several FDA-industry journals, and is a co-author of the book Best Practices in Biotechnology Business Development. In addition, Mr. Avellanet writes and publishes the monthly executive compliance intelligence newsletter, SmarterCompliance™.

If you are a journalist or editor and would like a copy of the article, or if you’d like to add Mr. Avellanet as one of your source experts, please contact him directly: john @ceruleanllc.com.

To learn more about having Mr. Avellanet speak for your conference or conduct an on-site workshop for your company, please contact him directly: john @ceruleanllc.com.

To learn about how to reduce your risks and costs, join the SmarterCompliance™ program.

Cerulean Associates LLC is a private advisory company that helps executives in the pharmaceutical, biotech and device sectors cut costs, streamline quality systems, speed new drug, biologic or device time to market, and protect their intellectual property from theft. Cerulean publishes the SmarterCompliance™ newsletter as part of its FDA executive advisory program, the SmarterCompliance™ program. On the web at www.ceruleanllc.com.

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