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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"

Audit Like An

​FDA Auditor

Welcome to our site...

Biotechnology

"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.

Emerging

​Technologies

Former FDA National Expert Investigator

​​Former FDA National Lead Instructor

Sterility Assurance

Issues

Data Integrity

Issues

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

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• 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

Rebeca Rodríguez

"Avoid Expensive Product Recalls"

Quality by

​Design

"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.” ™ 

TM