Our staff is comprised of medical professionals, former FDA inspectors, Fortune 500 Quality, Regulatory and Compliance executive managers

Quality and Compliance for Pharmaceuticals, Medical Devices, Supplements and Biologic.

Our staff brings together seasoned medical professionals, former FDA inspectors, and top-tier Fortune 500 executives with proven track records in quality, regulatory affairs, and compliance.

Founded in 2013, our company addresses the critical need for quality and compliance information within the life science industry. ComplyFDA.com is the culmination of over two years of intensive development. Our expert team includes medical professionals, former FDA inspectors, and Fortune 500 leaders in quality, regulatory affairs, and compliance – boasting over 85 years of combined experience.

We specialize in clinical research, design controls, and manufacturing quality systems for organizations of all sizes. Our staff are established industry authors, certified in process excellence and six sigma, and recognized by Fortune 500 companies for their innovative approaches to quality. We are unwavering in our dedication to quality and compliance.

Meet Our Team

Implement, Deploying, and Maintaining Quality Management Systems

Michael Kuehne
Michael KuehneContributing Editor
Michael is a recognized quality professional whose expertise in quality systems spans medical device, pharmaceutical, gene therapy and biologics industries. His experience includes multiple senior management positions in size organizations from startups to Fortune 100 including contract manufacturers.
Alice Krumenaker
Alice KrumenakerExperienced Quality and Lab Compliance Professional
• Process improvement: Analyze current processes, perform gap analysis, design andimple ment improvement plans
• Oversee change control process
• Plan and conduct site quality training
• Global Specification Committee Coordinator: Review proposals, coordinate and facilitate meetings, take and distributes minutes
Maria Alvarez
Maria AlvarezSr. Global Account Director at Healthcare Triangle
Seasoned Executive with a proven record of establishing and maintaining strong client relationships, and identifying and delivering comprehensive Management Consulting, Advisory, ECM, Commissioning and Decommissioning Services of Systems and sites, as well as Systems Integration Services
John Thorn
John ThornDirector of Quality for Oceana Health
Win Nutrition (Nutritional supplements industry). 35+ years as a senior level quality and operations professional within various manufacturing organizations inclusive of medical, aerospace, military and commercial products. Seven of those years as a  senior level supplier quality engineer.
Jennifer Sparrow
Jennifer SparrowQuality Compliance Expert | Business Transformation | Former FDA Inspector
Accomplished leader in Life Sciences with emphasis on Business Transformation, Quality System Management, Compliance, and serving as coach and mentor. I utilize my Compliance expertise to proactively merge regulatory expectations into business processes in a simple and meaningful way.
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