Quality and regulatory expert partners

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Minnesota, USA
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Quality and Regulatory Advisor
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MedTech, BioTech, Pharmaceuticals, Medical Devices
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Worldwide

Areas of Expertise

Based in Minneapolis, MN, and the heart of MedTech and BioTech innovation, Quality & Regulatory Expert (QRx) Partners strives to be the partner of choice for companies that want to realise clear business benefit from their regulatory and quality management system investment in terms of effectiveness, efficiency, risk management, compliance, and operational excellence. They can help you avoid adverse regulatory actions, ensure timely market access, and effective post-market follow-up. With over 85 years of combined experience among their expert Partners: Jackie Torfin, Mark Swanson & Steve Gompertz, QRx strives to support its customers to ensure that their investment in consulting services provides sustainable business value beyond compliance and produces results favorable to the business.

Working with GTM Global

GTM is delighted to partner with QRx, who provide effective and added value quality management systems to ensure critical compliance for ambitious high-growth MedTech devices, Pharma, BioPharma, CRO and Academia companies looking to expand into North America and globally.

Principal Services

Quality System Assessment & Auditing

Quality System Development & Improvement

Education & Training

Software Solutions Services

Regulatory Submission Support

Regulatory Interaction Support

EU PRRC Representation

Key Advisors

Steve Gompertz

Chief Operating Officer & Partner

Steve has been a leader in Quality Systems management for 30 years. His career includes roles in quality systems development and implementation, project management, engineering automation, configuration management, audit, and software development for companies including Pelican Biothermal, St. Jude Medical and Boston Scientific.

Mark Swanson

Healthcare Regulatory Advisor

Mark has been a leader in Quality and Regulatory for over 25 years. His career includes roles in quality engineering, design assurance, audit, and quality management for companies, including St. Jude Medical and Medtronic, and has provided guidance to numerous medical device and pharmaceutical manufacturers of all sizes.

Jackie Torfin

Partner / Client Relations and Marketing

Jackie has over 30 years experience and deep expertise in quality, regulatory, pre-clinical and clinical compliance. She has served in Senior Global roles for companies including Beckman Coulter, NAMSA, CIMA Labs, PDL BioPharma, Arizant/3M, and Heraeus.

Christina Pecoraro

Account Manager

Bringing over a decade of experience, Christina has been employed in quality assurance, medical device regulatory affairs, and business development. She gets involved in supporting all sizes of medical device companies such as Boston Scientific and Medtronic, to small startups.

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Useful Resources

Navigating US Compliance and Regulation as a UK Life Sciences Firm

Essential insights on navigating the stringent US regulatory landscape, particularly FDA requirements, to successfully enter and sustain presence in the US market.

Like to Access the GTM Ecosystem?

Does your company supply products or services that add tangible value to tech/digital scale-ups in international expansion mode? Contact us to find out how you can become a collaborator, partner or sponsor within the GTM Ecosystem.