• Independent Quality and Regulatory Auditor
  • Mock FDA Inspections Consultant
  • Former Supervisory Investigator, U.S. FDA Office Of Regulatory Affairs
  • District Medical Devices Program Monitor
  • International Inspection Cadre – Medical Device Group
  • Compliance Officer, FDA Office Of Regulatory Affairs
  • Investigator, FDA Office Of Regulatory Affairs
  • Chemist, FDA Office Of Regulatory Affairs
  • FDA Investigator Performance Auditor Certification
  • FDA Investigator Certification

Our FDA Consultant was a national expert in the laws and regulations governing unapproved new drugs and dietary supplements. As a former FDA Compliance Officer, he reviewed and approved or disapproved Warning Letters, seizures, and injunctions. As such, he has extensive knowledge of 21 USC when taking action against unsafe products in the U.S. market. Furthermore, he reviewed product labels and ensured that the information was truthful and not misleading.

As a former FDA Investigator, our FDA consultant performed establishment inspections from the simple to the most complex type.

In addition, he issued numerous FDA Form 483, Inspectional Observations, to the firms violating the FD&C Act and codes of the Code of Federal Regulations Title 21 (21 CFR) that require firms to adhere to Quality System Regulation (QSR). Also, he collected numerous documentary samples to establish FDA jurisdiction for required legal intervention by the FDA. Contact us to schedule mock FDA inspections by a former United States Food and Drug Administration Field Office Investigator.

Why Our FDA Consultant

Finding an ex-FDA inspector for your FDA consulting is crucial for pharmaceutical and medical device manufacturers. Actually, we can help manufacturers meet their most challenging roles—complying with US FDA laws and regulations.

We have helped numerous manufacturers with diverse scenarios. 

At ALPS FDA Consulting, we are passionate about making a difference, and this passion is one of the core features that keep us highly motivated in our mission of providing FDA consulting. Our ex-FDA inspectors assist in preparing for FDA inspections while following the latest FDA guidelines for evaluating your quality system.

Contact us to schedule

Contact us to get started with our well-qualified FDA consultant. Also, our availability is limited.