SRS Inc. provides regulatory affairs and quality assurance consulting services for medical device manufacturers doing, or planning to do business in the USA, European Union, Canada and Latin America. Our services include product registrations, quality system creation and auditing as well as hosting inspections and resolving regulatory matters.
http://www.strategicregulatory.com/
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Gustavo Kobrin
8502 E. ●●●●●●●● PMB 234
Or●●ge , CA, 92869
US
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Gustavo Kobrin
Kobrin, Gus
8502 E. ●●●●●●●● PMB 234
Or●●ge , CA, 92869
US
View this contact
Gustavo Kobrin
Kobrin, Gus
8502 E. ●●●●●●●● PMB 234
Or●●ge , CA, 92869
US
View this contact
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NETWORK SOLUTIONS, LLC.
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Strategic Regulatory Solutions| Gustavo Kobrin President | strategicregulatory.com Reviews
https://strategicregulatory.com
SRS Inc. provides regulatory affairs and quality assurance consulting services for medical device manufacturers doing, or planning to do business in the USA, European Union, Canada and Latin America. Our services include product registrations, quality system creation and auditing as well as hosting inspections and resolving regulatory matters.
strategicregulatory.com
Strategic Regulatory Solutions| Services
http://www.strategicregulatory.com/services.html
SRS, Inc. provides the following services:. Internal and supplier audits. Registration and licensing documents such as 510(k), IDE, PMAs and Technical Files*. Registration strategies- USA, EU, Australia and Canada. Registration and licensing documents such as 510(k), IDE, PMAs and Technical Files. Establishment licenses and registrations. Company representation during regulatory inspections. Response to regulatory actions such as FDA Warning Letters and FDA 483.
Strategic Regulatory Solutions| Links
http://www.strategicregulatory.com/links.html
American Society for Quality. Advanced Medical Technology Association (AdvaMed). European Association for Notified Bodies for Medical Devices. Food and Drug Administration (FDA-CDRH). Food and Drug Law Institute (FDLI). International Medical Device Regulators Forum (IMDRF). Health Canada- Therapeutic Products Directorate. Notified Body Operations Group (NBOG). Orange County Regulatory Affairs Discussion Group (OCRA). Web Master - Taylor Sanderson.
Strategic Regulatory Solutions| Clients
http://www.strategicregulatory.com/clients.html
SRS, Inc. has extensive experience with companies ranging in size from two to thousands of employees. Our clients produce devices of all device classifications for distribution in the USA, European Union, Canada, Latin America and Australia. References are available upon request.
Strategic Regulatory Solutions| Locations
http://www.strategicregulatory.com/locations.html
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Strategic Regulatory Solutions| Gustavo Kobrin President
Welcome to Strategic Regulatory Solutions, Inc. Medical Device Regulatory Affairs and Quality Assurance Consulting Services. Gustavo Kobrin, President. SRS, Inc. provides a wide range of assistance in the fields of Quality Assurance, Regulatory Compliance and Regulatory Affairs for the medical device industry. Our goal is to help companies maintain their competitive edge through cost effective compliance and product registration strategies to help you succeed.
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