Cerulean’s John Avellanet has become an internationally respected expert by helping firms fix FDA quality systems, regulatory affairs programs, IT compliance efforts, and records management & document retention issues.
What Cerulean will do
- explain why the consultant’s work was substandard
- show you how the compliance components should have been optimized
- clarify what needs to happen, the priorities and options
- review the benefits you’ll see from improvements
- fix each compliance component properly
- transfer knowledge so you can make more informed decisions in the future
- give you twelve months of free help with any future audit or inspection
- minimize your risks and maximize your success
Are you seeing too many little red flags with the current consultants you have? Maybe it’s time to call someone FDA inspectors recommend.
Dependable proof
- Cerulean’s triple guarantee – including one full year of audit and inspection help
- previous client testimonials and references
- compliance articles, reports, case studies, books and recorded seminars
- adherence to industry and professional codes of conduct and ethics
- Better Business Bureau accreditation
Learn more about working with Cerulean.
Lean compliance expertise
- Lean FDA quality systems and regulatory affairs
- IT Compliance (Part 11 and Annex 11)
- Cost-effective, expert workshops and FDA training
- FDA records management and defensible document retention
- Due diligence supplier audits
