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.

Principal & Chief Executive Officer

Michael Kuehne

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.

As Principal of ComplyFDA.com, Michael leads the development of transformative quality and compliance solutions for the life sciences industry. With a distinguished career spanning Fortune 50 organizations, innovative biotechnology firms, and early-stage ventures, Michael translates over 25 years of high-level industry experience into actionable intelligence for global life science organizations.

Industry-Leading Innovation

Michael has pioneered proprietary compliance intelligence solutions that fundamentally reshape how life sciences organizations approach risk management:

  • Intelligent Insights™ Quarterly Reports: Delivering strategic foresight through comprehensive 24-month rolling analyses of FDA compliance trends used to objectively identify regulatory risk.
  • Proprietary FDA Compliance Database (2012-2025): Leveraging an unparalleled repository of regulatory data to provide sophisticated benchmarking solutions, custom dashboards, real-time visualizations, and training frameworks for life sciences
  • GxP and Baseline Assessments: Implementing a proprietary assessment methodology integrating Regulatory Risk derived from an extensive database of FDA compliance trends. Benchmarking an organization’s “current state” against validated best practices, the process provides an objective diagnostic and prioritized strategic roadmap.

Michael has held senior leadership positions across biotechnology firms, Fortune 50 medical device organizations, and pharmaceutical manufacturers. Key contributions include:

  • Leading global process engineering for drug eluting stents (the birth of combination products)
  • Spearheading organizational compliance transformations and successfully transitioning operations from clinical development to commercial manufacturing
  • Reducing product development cycle times while achieving ISO 13485/9001 certification, and authoring published thought leadership on QMS excellence
  • Lead innovation of clean room biological safety cabinets (Patent number 14721124)

Michael’s consultative methodology encompasses:

  • Quality System Transformation: Architecting quality management systems to elevated performance through validated methodologies and objective, data-driven assessment frameworks
  • Cultural Architecture: Facilitating organizational cultures of compliance excellence
  • Regulatory Excellence: Successfully guiding organizations through rigorous FDA and notified body inspections
  • Risk-Based Innovation & Strategic Planning: Implementing advanced risk-intelligent strategies while crafting comprehensive multi-year quality and compliance roadmaps

Michael’s proven ability to recognize organizational vulnerabilities, implement effective improvement plans has earned him recognition as a trusted advisor and thought leader in the life sciences quality and compliance community.

Michael continues to develop next-generation strategies, intelligence tools, and analytical solutions that empower life sciences organizations to navigate regulatory complexity, optimize risk management, and consistently deliver high-quality products that improve patient outcomes.

Experienced Quality and Lab Compliance Professional

Alice Krumenaker

• Process improvement: Analyze current processes, perform gap analysis, design and implement 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

Sr. Global Account Director at Healthcare Triangle

Maria Alvarez

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

Director of Quality for Oceana Health

John Thorn

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.

Quality Compliance Expert | Business Transformation | Former FDA Inspector

Jennifer Sparrow

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.