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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

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

Cerulean's John Avellanet has the expert knowledge and the real life experience to get quality systems up & running fast. For our QA system, he quickly showed us: (1) how to prioritize quality and regulatory compliance solutions by risk to patient and risk to the business; and (2) how to take a typical SOP and turn it into a streamlined, flexible process. Cerulean's practical approaches are wonderful.

- Allan Staley, President, Hampton, Virginia

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