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Welcome New Visitors!

I'd like to extend a warm welcome to you.  To help you get the most out of this and future visits, we've included short overviews of the major resources we offer below.

As you'll soon discover, we're constantly posting new articles, new tips, tools, and resources, so be sure to bookmark the site!

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   The SmarterCompliance™ Newsletter

Read by executives and business owners in over 14 countries, the SmarterCompliance™ newsletter is packed with solutions and actionable advice to help you improve FDA compliance, enhance your expertise, increase your bottom line, and create powerful results.  To learn more, Click Here.

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   Featured Online Seminar & Resource Kit

This month we're focusing on FDA enforcement in our compliance webinar series.

If you're looking for independent advice that will clearly explain evolving FDA expectations, how to stay ahead of the inspectors, and give you tools you can easy and quickly put to use, check out our monthly online compliance seminars ... all of which have a risk-free, money-back guarantee.

For senior managers and executives who need proven, powerful compliance advice and tactics to kick start a lean FDA quality system and keep it going strong, SmarterCompliance™ seminars and resource kits are the guides of choice.  Everything else is just a sales job.

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   Published Articles, Case Studies and Industry Reports

From industry cover articles, client case studies and special industry reports and workbooks, you'll find everything from simple advice you can use today to long-term strategies for success.  We update this monthly, so get on our "update me" mailing list.

If you're an executive, CEO, or senior manager needing independent expert answers you can rely on and step-by-step advice you can put right to use every month, take a look at our FDA advisory  SmarterCompliance™ Toolkit program.

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   Recorded Seminars, e-Courses and Workshops

In need of the most current FDA compliance best practices?  We've got you covered with our recorded seminars and resource kits.  You'll find everything from "how-to" basics to in-depth roadmaps and recommendations.  We're constantly updating this department every month, so get on our "update me" mailing list.

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   Specialized Consulting and Auditing Services

We have particular expertise in GLP, GMP, ICH and GHTF quality systems for pharmaceutical and medical device firms, FDA Quality by Design, records management, intellectual property security, and IT compliance strategies (FDA Part 11 and EMEA Annex 11).

Every one of our specialized services comes with 12 months of free inspection support so you don't need to worry about facing FDA inspectors all alone.

Check out our popular article, Getting the Results You Expect from Consultants, and our FAQs, and then head over to our adjunct page to find even more resources.

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   Client Results and Testimonials

Take a look at the specific client results we've achieved, our client and newsletter subscriber testimonials, and the feedback from webinar, onsite workshop and keynote speaking events. 

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   Details about Cerulean, the Latest News and FAQs

Want to know more about Cerulean, how to pronounce our name, the latest news, or why on earth we're not more like all the other traditional regulatory affairs or quality assurance consulting firms?  You can learn everything in our About Cerulean section.

Not only will you find answers to frequently asked questions, we'll give you reasons not to hire us!

With that quick overview, you're ready to get started!  I hope you enjoy your visit.  I look forward to helping you turn your FDA quality system into a competitive advantage!

John Avellanet

Managing Director

Cerulean Associates LLC

 

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