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Cerulean in the News

John Avellanet to speak on supplier qualification and oversight do's and don'ts in a global economy.

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New reviews of Get to Market Now! available online from more journal editors and Amazon.com reviewers.

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Lean FDA Compliance

Cerulean is a small, boutique advisory firm specializing in simplifying and streamlining FDA, ICH and GHTF quality systems, regulatory compliance and records controls.

Minimize risk, lower costs, and speed your time to market with strategies, policies and controls that improve your compliance and strengthen your bottom line:

• Monthly FDA regulatory intel and expert quality systems tips in our compliance newsletter

• Online FDA compliance seminars and corporate workshops

• Audits - mock FDA inspections, warning letter closeouts, and revised FDA Part 11

• Lean compliance consulting - FDA quality system SOPs, strategies for Quality by Design and expert FDA records management and document retention help

 

New Visitors:  First time visiting our site?  Click here for an overview of everything we have to offer.  And don't forget to check out our managing director's Compliance Zen blog.  It's filled with dozens of tips and tricks to kick start your lean compliance in an instant.

 

Transform your FDA compliance into competitive advantage

We've helped some of the most prestigious companies, including Boehringer-Ingelheim, Otsuka, Sciele Pharma, and Eisai, and some of the most profitable startups like Soluble Systems, CROfessionals, and Chelsea Therapeutics.  See Cerulean's client results and many testimonials.

In any work together, you'll get:

• Process simplification

• Reduced overhead

• Improved effectiveness

• Real knowledge transfer

We don't sell with seniors only to service with juniors - when you work with Cerulean, you work directly with our founder, John Avellanet, author of the book Get to Market Now!, co-author of Best Practices in Biotechnology Business Development, publisher of the SmarterCompliance executive newsletter, and an award-winning business speaker.

 

Wondering if You Can Try Out Cerulean's Advice Risk-Free?

Subscribe today to our monthly SmarterCompliance FDA newsletter for expert quality systems tips, cost-effective FDA compliance tactics, proactive regulatory affairs practices, and crucial records retention advice. Click here to learn more and download two free issues! 

Contact us today.  You'll be glad you did.

 

Get lean. Get compliant. Get Cerulean.