Quality Regulatory Consulting LLC

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5105 Fairoaks Rd
Durham, NC 27712
+1 (919) 383-3170

Quality Regulatory Consulting, LLC is a trusted and experienced consultancy based in Durham, North Carolina, specializing in providing compliance support to the pharmaceutical and medical device industries. With a certified ISO 13485 2016 Lead Auditor, they offer expert and affordable services, including audits of Quality Management Systems, to help companies meet FDA and ISO 13485 requirements.

With a focus on quality management systems auditing and risk management services, Quality Regulatory Consulting, LLC ensures compliance with various regulations such as US FDA 21 CFR Part 820, European MDD AIMDD IVDDEU MDR AIMDR IVDR, and ISO 14971. Their team is dedicated to delivering rapid responses and tailored solutions to meet any budget, making them a reliable partner for companies in the medical device and pharmaceutical industries.

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