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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

FDA’s New Inspection Protocol Begins to Have Impact

December 20, 2016

The FDA’s New Inspection Protocol Project (NIPP) is expected to increase the likelihood of a drug manufacturing facility undergoing a pre-approval inspection from the current average of 30 percent to a target of 50 percent. “As a pharma company if you’re going to submit a new drug, instead of a 30 percent chance of getting […]

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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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