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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

Investor pressure is on for us to streamline our compliance activities and reduce overhead. And yet we still have to abide by FDA, EMA, MHRA, and dozens more regulatory health agencies. We struggled to bridge where we were versus where we needed to go. Mr. Avellanet came in, gave us a realistic plan we could all agree to, and in four months, we were finally on our way after nearly two years of struggling internally and with other consultants. Cerulean truly brings the insights and practical experience needed.

- Regulatory Affairs Senior Director, Multi-National Pharmaceutical Company, Iselin, New Jersey

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