Streamline your FDA compliance & strengthen your data integrity

How do I cut costs and simplify compliance…?

How do I ensure real-world data integrity…?

How do I check if I’ll pass an FDA inspection…?

How do I get onsite or virtual training…?

Please note that Cerulean is no longer taking new consulting clients. Thank you for your interest and check back in 2024.

John Avellanet, Managing Director

Compliance Services

Lean Compliance

Cost-effective, risk-based compliance can strengthen your firm's bottom line while simplifying your quality system. Streamline your SOPs to the 21st century.

Data Integrity

Help from the expert who trains FDA investigators and has been handling data integrity for more than 20 years. Audits, training, and advisory services.

Mock FDA Audits

Whether you're a contract lab, a manufacturer or handling clinical trials, Cerulean focuses its audits on real-world issues and risks with pragmatic recommendations.

Litigation Support

Cerulean provides litigation support to law firms on the real-world practicalities and subtleties of FDA regulations, quality systems, and data integrity requirements.

FDA Recordkeeping

Record retention for hybrid paper and digital records is challenging. Get help from a successful expert who's defended decisions to investigators and litigators.

Onsite/Virtual Training

If you need pragmatic compliance training from someone who trains FDA and private companies around the world; whether on site or remotely, contact Cerulean today.