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…?

John Avellanet was extremely helpful in assisting us to develop records and information management policies and records retention schedules that matched our FDA requirements and our resource capabilities. In addition, he managed our project expectations well and kept us on track and on budget.

Chih-Wu Chang, Senior Quality Manager, San Diego, California

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.

Upcoming Events

  • Oct 7th - Data Integrity Risks in Virtual Inspections
  • Oct 21st - Data Integrity and Cosmetic GMPs
  • Dec 1st - GCP Data Integrity Virtual Workshop
  • Dec 3rd - GCP Data Integrity Virtual Workshop
  • Dec 8th - GMP Data Integrity Virtual Workshop