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Consultants Inc.

3234 Ibis Street
San Diego, CA 92103

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Accurate FDA Consultants name

• Our Core Team

Glen Feye- President & Principal ConsultantGlen Feye, MS, and CQE -
Accurate FDA Consultants President and Founder. Mr Feye is a recognized expert industry consultant and speaker. He has over 20 years of experience in Quality Assurance, Quality Control, and Regulatory Affairs. Mr. Feye has authored device, biologics and drug submission. He has assisted clients resolved over 20 Warning Letters.

Andreas Kern, Ph.D.Andreas Kern, PhD. -
Dr. Kern is a RA/QA Consultant with over 10 years of industry experience in product development, regulatory and quality assurance/control in the FDA regulated medical device industry. Dr. Kern’s expertise includes 510(k) submissions, development and maintenance of efficient and effective quality systems based on QSR and ISO 13485, and sterilization. Dr. Kern was head of Quality at a start-up company manufacturing implantable sterile suture-related products. Dr. Kern received his doctorate in protein chemistry at LMU in Munich, Germany. His scientific background includes assay development, tissue engineering, as well as grant writing expertise. He is fluent in German and English.

Barney King, MD, MBA - Dr. King is a highly talented Executive Regulatory and Clinical consultant. Dr. King is a recognized medical industry expert and has over 30 years experience in the Research and Development, Clinical and Regulatory Affairs in both the medical device and pharma industries. Dr. King’s regulatory and clinical affairs expertise includes developing regulatory and clinical strategies, interactions with FDA, and execution of the clinical protocols and studies.

Carol Cox-McClave MA- Ms Cox-McClave is an expert medical research process auditor, specializing in auditing computer systems. Provides both GCP and GLP services, auditing and training to pharmaceutical, biopharmaceutical, medical device companies, contract research organizations and academic institutions She also is an expert in Software QA.