Specialized Consulting Services

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 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
• FDA, ICH & IMDRF quality systems training

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

Litigation support

Forced to show how your SOPs & policies maximized safety and regulatory compliance? Or need expert FDA compliance help to build a case? See our Litigation support services

Learn more

• Working with Cerulean
• Consulting pricing levels
• Cerulean’s 12-month triple guarantee