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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 provides excellent advice that is both compliant and reasonable. He also works within the constraints of a company’s business realities when providing advice. This has helped integrate the controls into our company much faster and for a lot less; with our small staff and low budget, this has been extremely helpful. I would recommend Cerulean for small to mid-size firms that need to be in regulatory compliance with the FDA and want to get to market (or partnership) quickly.

- Michael Weber, Director of Quality, Williamsburg, Virginia

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