Practical advice, proven strategies and experience-based insights – approved by FDA inspectors – to reduce risk, lower costs & improve your competitive edge
FDA compliance assessment
Need an independent snapshot of your FDA compliance status? Or a mock inspection of your critical suppliers? See our Mock FDA audit service.
Fix a previous consultant’s work
It’s “buyer beware” when hiring a contractor. Cookie-cutter SOPs, too many shortcuts and sloppy knowledge transfer leave you at risk. Review our Compliance repair service and our full year triple guarantee.
Prefer a “go-slow” approach?
- Subscribe to our Client newsletter – every other month you’ll get insight into emerging and existing legislation, regulation and guidelines, with FDA quality systems tips, interviews with former FDA officials, and more
- Find a Recorded compliance seminar that’s right for you
- Bring in Cerulean’s managing director for a private corporate workshop
- Get your copy of Get to Market Now! Turn FDA Compliance into a Competitive Edge in the Era of Personalized Medicine, the book reviewers have called “a blueprint for the successful & compliant company“
Lean quality systems
- FDA quality system design and remediation
- Interim quality management
- Lean regulatory affairs processes
- Supplier due diligence
- Cost-effective FDA Part 11 compliance
- Private corporate training on current FDA compliance challenges
Supplier management help
Get control of suppliers, ensure compliance with quality agreements and regulatory requirements, and put in place an FDA-approved supplier qualification and oversight process
Forced to show how your SOPs & policies maximized safety and regulatory compliance? Or need expert FDA compliance help to build a case? Or need to find a well-respected, and known corporate integrity agreement IRO? See our Litigation support services
- FDA records retention for GMPs, GLPs, GCPs and QSR
- Consolidate of state, US and international record requirements
- Defensible documentation
- Conformity with FRCP & FDA Part 11 rules for e-records