Solve compliance problems, lower costs & reduce risk with trusted consulting and training to streamline
FDA compliance & strengthen your data integrity
Find out how →

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

See the schedule Request Training

Latest Article

Expert Advice on Data Integrity Issues – Excerpt

October 2, 2015

The FDA has cited data integrity as one of the most important GMP issues because it lies at the crux of all cGMP systems. John Avellanet, managing director and principal at Cerulean Associates, sat down with FDAnews to talk about how companies should be handling their data. Question: Are you seeing common themes running through […]

Read the article

Client Success Stories

Cerulean's John Avellanet took the bare bones of a document retention need, and applied the FDA regulations, the EMA rules, and the ISO guidelines to the daily realities of our business. With John's help, we were able to develop a top-notch records retention policy and matrix that actually sticks, providing needed benefits for years to come. We could not have been happier with Cerulean's work product, professionalism, or positive attitude throughout the project.

- Leslie Wood, Associate General Counsel, Leesburg, Virgina

Read more success stories