QMB is a strategic consulting partner in transforming quality and Regulatory business units from a cost center to a profit driver. We utilize our collective experience in RA/QA, Product Development, Strategy, Market, and Clinical Research to develop and deploy strategic quality management systems, develop FDA product submissions, empower clinical trial management, and actualize regulatory requirements. We assist and work with your in-house regulatory and product development teams to ensure optimal results.
Our other passion:
By compiling our industry experience, we are taking the world of regulatory product clearances and approvals into the next phase by developing a new AI-native platform called QualiVerse â„¢. This platform will be able to automate the heavily manual nature of regulatory research and product strategy, accelerate the planning and implementation of submissions, and de-risk the highly demanding submission preparation process. Follow QualiVerse_AI on LinkedIn.
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Industry
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Medical and Diagnostic Laboratories
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Company size
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2-10 employees
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Headquarters
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Boston, Massachusetts
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Type
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Privately Held
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Founded
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2020
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Specialties
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Combination Product, Medical Device, US FDA, EU EMA, Pharmaceutical, PMA, RA/QA , 510K submissions, and Regulatory Strategy
