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Services

What We Do

FDA Consulting provides clients with expertise in the FDA/Compliance regulated industries.  Our ability to bring talented experts to the clients site allows immediate remediation activities to take place.  FDA Consulting has a foundation built on Quality and Integrity.  Honest relationships creat long lasting partnership with our clients as well as our experts. 

 

Any organization in the FDA regulated environment require the best quality systems with continuous improvements set in their systems.  We are here to make sure that clients have the resources required to fulfill the needs of this regulated industry.  We have experience in the Medical Device industry.  Let FDA Consulting get you prepared for your next FDA audit, or allow us to assist in remediation activities.  

Quality Systems and Regulatory

We specialize in Quality Engineering, quality remediation, Gap Analysis, Risk Management (PFMEA/DFMEA), CAPA, NCR, Auditing, Compliance Engineering, and Regulatory Affairs.

Process Improvement/Validation Services

We Specialize in Validation Activities and Process Improvements.  Documentation Control, Test Method Validations, Six Sigma Process Controls and improvements.

Practice Areas

  • Quality Engineering

  • Validations

  • Process Improvement

  • ​Six Sigma

  • Regulatory Affairs

  • Design & Engineering 

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