© CERULEAN ASSOCIATES LLC

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

  • Comprehensive, easy-to-follow SOPs and policies – FDA & ISO
  • Mock FDA quality systems inspections and gap analyses
  • Streamlined FDA compliance
  • Program development, implementation and training
  • SOP writing, review and improvement
  • Supplier qualification best practices based on 16 years of experience
  • Process mapping & value stream analysis
  • Development of risk-based SOPs and policies in line with regulatory requirements, best practices guidance and business needs
  • Specialized corporate workshops on process mapping for compliance, FDA record keeping and document retention, IT compliance, and more

Receive

  • Compliance with GLP, GCP, GMP and QSR regulations plus ICH and IMDRF standards
  • Adherence with current 21 CFR Part 11 expectations
  • Conformity to ISO guidelines
  • Personalized, individual attention and expert advice from someone who’s walked in your shoes and passed multiple inspections
  • A complimentary subscription to our client FDA newsletter to keep your operations effective and proactive

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