One-on-one time and help from a compliance executive and FDA expert
If you’re looking for personalized insight you can count on, author John Avellanet will walk you through the steps you need to take to develop and implement a plan for smarter compliance so get to market faster, with less risk and less cost, all while turning FDA compliance into a competitive business edge.
Compliance Consulting that Delivers Real Results
John Avellanet is the person to call when you’re tired of getting the same platitudes and black & white thinking from consultants and experts who’ve never run a business in their life or had to defend decisions to inspectors and litigators. Mr. Avellanet has lectured, trained, inspired, and implemented lean compliance components to pharmaceutical, biotechnology, and medical device firms from Japan to Europe, India to Finland.
He’s the author of Get to Market Now! Turn FDA Compliance into a Competitive Edge. He’s also a contributing author to Best Practices in Biotechnology Business Development.
Specialized Services Portfolio
Program Implementation | Improvement
- Lean regulatory compliance – FDA, EMA, ICH, GHTF
- Lean records management and document retention
- Policy and SOP writing and process mapping
Auditing | Inspections
- Mock FDA audits and gap analyses
- Warning letter, FDA-483 intervention and recovery
- Supplier due diligence audits
- Corporate espionage reviews
- Records management compliance
Compliance Intelligence | Executive Advising
- Corporate workshops – onsite, teleconference, or webinars
- Executive retainer – regulatory affairs, quality system, records management compliance
- Regulatory intelligence publications
- Expert litigation support
- Conference and keynote speaking
To learn more, visit Mr. Avellanet’s specialized compliance consulting services page at the Cerulean website.
