Lean Compliance for Quality Systems
Cost-effective compliance that FDA and investors approve
Designed exclusively for small companies and midsized firms, Cerulean’s expertise draws upon career experiences implementing quality systems, simplifying SOPs, managing vendors, conducting audits … and successful FDA inspections.
Cost-Effective, Low Overhead Frameworks
- Simplified, easy-to-follow SOPs and policies for FDA & ISO compliance
- Mock FDA quality systems inspections and gap analyses
- Streamlined FDA compliance
- Program development, implementation and training
- Modern SOP writing, review and improvement
- 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 modern SOPs, FDA record keeping and document retention, data integrity, and more
Receive
- 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.
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