Company profile
One Way Consultants, LLC, FDA Regulatory Experts
If you have an FDA problem, we can help you solve it. If you want to avoid an FDA problem work with us now!
- Industry
- Medical Equipment Manufacturing
- Employees
- 3
- Headquarters
- East Alton,, IL
- Founded
- 2011
- LinkedIn followers
- 359
- Office locations
- 1
One Way Consultants, LLC, FDA Regulatory Experts company summary
One Way Consultants, LLC, FDA Regulatory Experts is a company in the Medical Equipment Manufacturing industry, headquartered in East Alton,, IL, founded in 2011. On LinkedIn the company has around 3 employees and 359 followers. Its listed specialties include Mock FDA Audits and Remediation Plans, Designing Clinical Trials, Training employees on all aspects of FDA requirements., Preparing stategic RA/QA plans for new companies., Serving as an Expert Witness on Medical Devices and FDA.
What technology does One Way Consultants, LLC, FDA Regulatory Experts use?
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About One Way Consultants, LLC, FDA Regulatory Experts
Specialties Planning, creating and auditing quality systems. Creating clinical plans including protocol development, case report form development, implementing and managing clinical trials. Design control to meet FDA requirements. I am a professional speaker who can train persons on all aspects of FDA requirements, and practical and successful solutions to FDA problems I have over 20 years of FDA experience encompassing virtually all of the FDA field positions. I also have eighteen years of industry experience as a mid-level manager and senior executive in clinical, regulatory, and quality in the medical device industry. I have personally designed quality systems, prepared regulatory submissions (510(k), IDE and PMA) and managed 7 multi-center clinical trials for class 3 medical devices. From 1989-1993, I was the Industry Representative on the FDA Circulatory Systems panel. Finally, I am a seasoned educator/speaker with over 250 public presentations to audiences ranging from senior executives, physicians, technical personnel, other medical personnel, major media, and the general public. 3124-499-5148
Specialties
Where is One Way Consultants, LLC, FDA Regulatory Experts located?
One Way Consultants, LLC, FDA Regulatory Experts lists 1 location.
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| Company | Industry | Employees | Founded | Headquarters |
|---|---|---|---|---|
One Way Consultants, LLC, FDA Regulatory Experts fdadeviceexpert.com | Medical Equipment Manufacturing | 3 | 2011 | East Alton,, IL |
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 Olympus Corporation olympus-global.com | Medical Equipment Manufacturing | 13,703 | 1919 | Shinjuku-ku, Tokyo |
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Frequently asked questions about One Way Consultants, LLC, FDA Regulatory Experts
What does One Way Consultants, LLC, FDA Regulatory Experts do?
Specialties Planning, creating and auditing quality systems. Creating clinical plans including protocol development, case report form development, implementing and managing clinical trials. Design control to meet FDA requirements. I am a professional speaker who can train persons on all aspects of FDA requirements, and practical and successful solutions to FDA problems I have over 20 years of FDA experience encompassing virtually all of the FDA field positions. I also have eighteen years of industry experience as a mid-level manager and senior executive in clinical, regulatory, and quality in the medical device industry. I have personally designed quality systems, prepared regulatory submissions (510(k), IDE and PMA) and managed 7 multi-center clinical trials for class 3 medical devices. From 1989-1993, I was the Industry Representative on the FDA Circulatory Systems panel. Finally, I am a seasoned educator/speaker with over 250 public presentations to audiences ranging from senior executives, physicians, technical personnel, other medical personnel, major media, and the general public. 3124-499-5148
How many employees does One Way Consultants, LLC, FDA Regulatory Experts have?
One Way Consultants, LLC, FDA Regulatory Experts has around 3 employees on LinkedIn.
Where is One Way Consultants, LLC, FDA Regulatory Experts headquartered?
One Way Consultants, LLC, FDA Regulatory Experts is headquartered in East Alton,, IL.
When was One Way Consultants, LLC, FDA Regulatory Experts founded?
One Way Consultants, LLC, FDA Regulatory Experts was founded in 2011.
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