fda_logoFDA Quality and Regulatory Consultants LLC offers specialized Quality and Regulatory Consulting for Pharmaceutical, Medical Device and Biotech companies. Due to our Food and Drug Administration experiences, we provide customized, value-added solutions, processes and enhanced quality standards to optimize business efficiencies and minimize regulatory risk.


 The right compliance solution            A personal leadership team             Global independent experts              Home-based Project Manager

  • We do more than audits; we collaborate with you to analyze your need and match the right expert to your situation.
  • Our global team is recognized as experts in quality assurance and regulatory affairs providing expert advice to pharmaceutical, medical device and contract research organizations in pre-clinical, clinical and commercialized sectors.


“The mock inspectors are challenging our audit logistics in addition to our Quality Systems, Clinical Operations and overall compliance.” QA Audit Manager