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Solve compliance problems, lower costs & reduce risk with trusted consulting and training to streamline
FDA compliance & strengthen your data integrity
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Upcoming Events

Join Cerulean's John Avellanet at these upcoming cGXP training workshops, webinars, and conferences. Sessions include data integrity, supplier quality oversight, FDA recordkeeping, quality system best practices, and preparing for inspections from FDA, EMA and ISO.

"Simply put, John Avellanet is the best in the business. Period."
- N. Singer, former US DOJ and FDA prosecutor

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Latest Article

Consultant Audit Reports – Get What You Need

August 25, 2015

The independent, third-party audit is an essential component in any executive’s toolkit of sustainable quality and compliance. Such reports can come in all shapes and styles, from the high-level two to three-page summary to a minutely detailed, three hundred page bound monograph. How best to ensure a report that meets your needs? It all starts […]

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Client Success Stories

John Avellanet at Cerulean came to our rescue. We started as a small medical device supplier to the US Defense industry and quickly grew into a company with over twenty products. Our processes were not keeping up with our growth. When we received a warning letter from FDA, John was there for us. He guided us through the process of bringing us compliant with the QSR and cGMPs, and helped us through the follow-up FDA inspection. Cerulean was there for us from start to FDA closeout letter.

- - Paul Harder, President, Gloucester, Virginia

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