Cerulean LLC is an independent consultancy specializing in FDA regulatory compliance, quality management, IT, records control, and new medicine development programs. Founded by FDA lean compliance expert John Avellanet, the company offers services such as Lean FDA Quality System & SOPs, FDA Part 11 & Data Integrity, FDA Recordkeeping, and Mock FDA Audits. Cerulean helps pharmaceutical, medical device, and biotech executives enhance compliance effectiveness, leading to better business flexibility and improved bottom-line results. Clients benefit from turning compliance into a competitive advantage through Cerulean's expertise in simplifying and streamlining FDA, ICH, and IMDRF quality systems and regulatory compliance.