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Accurate
Consultants Inc.

3232 Ibis Street
San Diego, CA 92103
619.291.3695



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619.291.3695


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accuratefdaconsulting.com

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OUR SERVICES

Our consultants assigned to your project are tireless and dedicated to deliver results. To learn more about the services we provide please click on the subject below and/or contact us with your specific project needs and requirements.

* Clinical
* Compliance
* Quality Systems
* Regulatory
* Training Solutions
* U.S. Agent

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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.

Donna Hartzfeld- RA/QA ConsultantDonna Hartzfeld, PhD -
Dr. Hartzfeld is an energetic RA/QA Consultant with over 10 years experience. She has almost 20 years of Quality and Laboratory compliance experience in API, pharmaceutical, biologics and medical device industries. Her expertise includes Chemistry and Manufacturing Controls, QA/QC Systems development and implementation, QC Laboratory Controls, GMP and GLP Auditing, cGMP Training Programs, and PAI Readiness Plans. Her technical Skills include Analytical Chemistry, Organic Synthesis, DNA Photochemistry.

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.