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"

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"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"

"The Efficient Production

of Quality Products"

"Avoid Costly Remediation Efforts"

"The Key to Process Understanding"

FDA Regulatory Compliance Advisors, Inc.

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