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Since 1987, our company has served the healthcare industries with expert regulatory, compliance and technical support. Over the past 30+ years, we have helped hundreds of domestic and international clients gain U.S. market approval, achieve compliance with FDA’s Good Manufacturing Practices and other regulatory and Quality System requirements, and ensure the quality of their products. AccuReg has been  recognized by FDA as a Third Party Consultant of Record, as we have helped multiple clients in the successful resolution of multi-facility Consent Decrees. And we are proud to be certified by the Women’s Business Enterprise National Chapter (WBENC) as a Woman-Owned Business since 2006.

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Our clients are developers and manufacturers of the following medical product types:

  • Medical devices and diagnostic products

  • Biological and biotech products

  • Combination products

  • Human cells, tissue, cellular and tissue-based products (HCT/Ps)

  • In vitro diagnostic (IVD) products for home and clinical use

  • Ethical (prescription) and OTC pharmaceuticals

  • Computer-controlled medical devices

  • Process and system control software and computer systems

  • Cosmetics

  • Food supplements ("nutraceuticals")


We have been privileged to work with some of the best innovators in the industry, including:

  • Abbott Diagnostics Division

  • Abbott Laboratories

  • Acclarent (Johnson & Johnson)

  • Alcon Laboratories

  • Bausch & Lomb Pharmaceuticals

  • Biosense Webster

  • Boston Scientific Corporation

  • Cardinal Health

  • Clay-Park Laboratories

  • Conor Medsystems (Johnson & Johnson)

  • Cordis Corporation (Johnson & Johnson)

  • DePuy

  • DOW Chemical Company

  • Edwards Life Sciences

  • Ethicon (Johnson & Johnson)

  • Ethox Corporation

  • FluoroMed LP

  • Greer Laboratories

  • Home Diagnostics

  • Ikaria

  • Johnson & Johnson Healthcare

  • Landmark Scientific

  • MD Anderson Cancer Center

  • MedNext Inc.

  • Medtronic

  • Nelco Laboratories

  • Nipro Corporation

  • Novartis

  • Phillips Medical

  • Promega Corporation

  • Roche Diagnostics

  • Siemens

  • St. Jude's Children's Research Hospital

  • Teva Pharmaceuticals USA

  • Vistakon (Johnson & Johnson)

  • Zimmer

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AccuReg S4 Process, FDA Regulatory & Compliance Consulting
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