Regulatory & Quality Systems

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Tailgate Safety Group is proud to have quality systems expertise backed by over 15 years of hands-on experience in pharmaceutical and medical device manufacturing. Our team specializes in project management, data analysis, quality control, and integrated systems management—ensuring continuous improvement across cGMP-regulated environments.

With credentials including ASQ-Certified Quality Auditor and Lean Six Sigma Black Belt, our professionals have led global regulatory audit preparations, EQMS streamlining, and cross-functional process enhancements. We bring deep knowledge of FDA regulations, ISO 13485 standards, and 21 CFR Part 11 compliance, along with extensive experience using enterprise platforms such as TrackWise and MasterControl.

At Tailgate Safety Group, we deliver audit-ready, data-driven solutions that empower organizations to elevate their quality systems and embed a sustainable culture of compliance and operational excellence.