TM

“Combining science with regulatory knowledge for optimized systemic solutions.” ™ 

FDA Regulatory Compliance Advisors, Inc.

Invest in FDA-RCA's regulatory experience, who understand the “c" in cGMP. We ensure that organizations stay up to speed on FDA regulations.

"Avoid FDA-483s and WLs"

Welcome to our site...

"The Efficient Production

of Quality Products"

"Avoid Costly Remediation Efforts"

"The Key to Process Understanding"

"The Road to Innovation and Manufacturing Efficiency” ™

We provide technical and FDA regulatory knowledge to lay the foundation for optimized processes and robust systems that are key in the prevention of FDA-483s and FDA Warning Letters.

FDA-RCA™ provides effective and efficient systemic solutions for:


  • Quality Assurance (QA)
  • Quality Control (QC)
  • Product and Process Development
  • Manufacturing Operations
  • Packaging and Labeling
  • Manufacturing and Batch Production Records
  • Non-Conformances, OOS and CAPA
  • Product Storage and Product Distribution
  • Product Complaints
  • Product Returns

"Avoid Expensive Product Recalls"