Our Company
Accurate FDA Consultants provide the experts, who deliver Regulatory, Quality, Training and Compliance services and solutions based on our client’s specific needs and requirements.
For over 25 years, Accurate FDA Consultants have been providing Value, Excellence and Satisfaction to our domestic and international clients.
Accurate FDA Consultants main office is located in San Diego, CA and has strategic Affiliates throughout the United States and in several international locations.
Our Mission
Provide excellent Service, Solutions and Results to our clients so that they are able to develop, manufacture, and market safe and efficacious products in the United States and around the world.
Our Policy
Our Knowledge, Integrity and Professionalism are the hallmarks of our services and work product. We partner with our clients to meet the appropriate FDA regulations and international standards in an efficient, effective, and timely manner.
Some of Our Clients
Serving North America Latin America Europe Asia
DeSoutter Medical
Bucks, United Kingdom
Eurosets SRL
Modena, Italy
Operating Room Innovations
San Diego, CA
Cerbomed GmBH
Erlangen, Germany
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Our Team
Glen Feye, MS CQE
Accurate FDA Consultants President and Founder
Dilip Ashtekar, Ph.D.
Pharmaceutical Microbiology, Sterility Assurance and Sterile Product Manufacturing Expert
Mario Gemar, Ph.D.
RA/QA Consultant - Europe Specialist
Sebastian Feye, RAC
Regulatory Affairs Manager, RAC Global - Medical Devices
Our Posts
New premarket submission route: FDA’s eSTAR Program from pilot to production by Oct 1, 2023
New Updated 2023 FDA Final Guidance Significantly Changing Premarket Submissions Requirements for Medical Device Software
Artificial Intelligence and Machine Learning Workflow Driving Innovative Medical Device Development
An Overview of FDA Inspections across Drugs, Biologics and Medical Devices
New Medical Device Pathway: Safety and Performance Based Pathway
2020 Over-the-Counter (OTC) Drug Monographs Reform Summary
Clients Served over the past 25 years... and counting!
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