Lean Compliance for Quality & Regulatory Affairs

Cost-effective compliance that FDA and investors approve

Designed exclusively for small companies, startups and midsized organizations, Cerulean’s expertise draws upon career experiences implementing quality systems, regulatory affairs programs, managing suppliers, conducting audits … and successful FDA inspections.

Cost-Effective, Low Overhead Frameworks


  • Compliance with GLP, GCP, GMP and QSR regulations
  • Adherence with current data integrity requirements and expectations
  • Conformity to ISO, ICH, and IMDRF guidelines
  • Personalized, individual attention and expert advice from someone who’s walked in your shoes and passed multiple inspections

Plus one full year of free follow-up support and advice if you’re ever audited or inspected.

Call +1 757 645 2864 or email us. We offer a free half hour consultation to new clients