Managing Director & Principal
He has trained FDA and Health Canada officials, spent over 15 years personally accountable for regulatory compliance, and has passed multiple regulatory inspections. He was personally trained by the authors of 21 CFR 11 to conduct FDA inspections himself. Mr. Avellanet has been called been called “the best in the business” by former FDA and Department of Justice officials.
Trusted by officials at FDA, NIH and the OIG, as well as by clients around the world, Mr. Avellanet provides practical, business-savvy solutions to strengthen compliance while lowering costs and reducing risk. He speaks frequently at industry conferences and organizations around the world.
- Best of Business – Small Business Commerce Association, 2009 and 2011
- Top 10 FDA Compliance Blogs – FDAzilla Editors and Readers Choice
- Top 50 Pharma / Biotech Blog – Biotechnology Graduate Students Association
- Lifetime Achievement – Who’s Who of Pharmaceutical & Device Executives
He founded Cerulean in 2006, and today is an internationally acknowledged expert, speaker and syndicated author on lean FDA compliance.
Mr. Avellanet’s most recent book, Get to Market Now! Turn FDA Compliance into a Competitive Edge, was featured at BIO 2011. He is a contributing author to the book Best Practices in Biotechnology Business Development, and publishes the monthly newsletter of quality systems tips and regulatory intelligence, SmarterCompliance.
Throughout his corporate career, Mr. Avellanet has been personally accountable for regulatory compliance and quality systems (including ICH, GHTF, FDA Parts 820 and 11), records management, and IT compliance.
Mr. Avellanet’s regulatory and quality expertise is based on his experiences having to put in place, live under, and be audited upon compliance programs for FDA, DEA, EPA and BIS regulations as well as ISO guidelines. He has since translated his mistakes and successes into client success stories – whether setting up flexible, risk-based GLP/GMP quality systems, putting in defensible document and record retention programs, conducting mock FDA audits, or helping companies recover from FDA inspections and warning letters.
Illustrative of Mr. Avellanet’s advice are:
- Lead author of two RAPS certification courses on supplier management
- Co-authorship of the book, Pharmaceutical Regulatory Inspections – A Practical Guide
- The book, Get to Market Now! Turn FDA Compliance into a Competitive Edge in the Era of Personalized Medicine (Logos Press) featured at BIO 2011
- Co-authorship of the book, Best Practices in Biotechnology Business Development
- Membership on the Pharmaceutical Quality by Design advisory panel and the editorial boards of several industry journals
- The FDA compliance and quality systems blog, Compliance Zen
- Awarded lifetime membership in the Who’s Who of top executives in the pharmaceutical and life sciences industries.
- Chosen as one of the foremost experts on FDA compliance during new product development by the worldwide 30,000 member Intota organization.
- Frequent guest appearances on radio programs Tomorrow’s Business and My Technology Lawyer
- Multiple interviews in blogs and print periodicals such as The Silver Sheet, Clinica, and Pharmaceutical Technology
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Mr. Avellanet is a member of the following professional and industry associations:
- Food and Drug Law Institute
- The Sedona Conference
- Regulatory Affairs Professional Society
- Institute of Validation Technology
- Society of Quality Assurance
- Association of Records Managers and Administrators International
- European Compliance Academy
- Global Consulting Network
Mr. Avellanet grew up in the Washington, D.C. area and worked for several local and state government leaders in Alexandria and Richmond, Virginia. He earned his Bachelor’s at the College of William & Mary in Virginia and his Master’s degree at the university of Kansas.
His consulting office is located in Williamsburg, Virginia near the College of William and Mary.
In addition to advising his corporate clients, Mr. Avellanet is a frequent guest lecturer for:
- College of William & Mary Mason School of Business
- Virginia Commonwealth University School of Business
- National Institutes of Health
Mr. Avellanet serves on the advisory boards of several industry and professional associations:
Previously, Mr. Avellanet served as a director-at-large board member for the Independent Computer Consultants Association and the IT Compliance Institute.