Accurate FDA Consultants

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Strategic and Effective Pre-Submissions

Strategic and Effective Pre-Submissions

The purpose of the FDA Pre-Submission Program* (formerly Pre-IDE) and Meeting with FDA  is to provide a mechanism for applicants through which they can request feedback...

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FDA Consultant Addresses “Notice of FDA Action”

FDA Consultant Addresses “Notice of FDA Action”

IN LIMBO ON THE BORDER – by Glen Feye FDA is the main gatekeepers for foreign Medical Devices and Drugs imported into the United States. If your shipment is...

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Our Core Team

Our experts are tireless and dedicated to delivering results.

Glen Feye, MS, and CQE

Glen Feye, MS, and CQE

Accurate FDA Consultants President and Founder

Andreas Kern, PhD.

Andreas Kern, PhD.

RA/QA Consultant

Barney King, MD, MBA

Executive Regulatory and Clinical consultant

Carol Cox-McClave MA

Expert Medical Research Process Auditor