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Bio-Reg Assoc., Inc. (Medical Device Consultants): Regulatory, Clinical, and Quality Assurance Consulting Services

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BIO - REG is a leading regulatory, quality, and clinical consulting company devoted to helping medical device, pharmaceutical, biotech, and biologic firms navigate through the FDA process. BIO-REG has a proven track record managing all aspects of regulatory affairs and is committed to compliance solutions that last. Strategically located near FDA in the Washington , D.C. metropolitan area, BIO-REG can work with you to make your regulatory path smoother and more efficient.

Founded in 1987, BIO - REG ’s success depends on its highly qualified and dedicated employees. Our senior management team consists of degreed, experienced professionals. These individuals, as well as our other consultants, have had successful careers with organizations such as AT&T, DOD, British Telecom, FDA, Abbott Laboratories, Becton Dickinson, General Electric Medical Systems, IGEN, Syntec Corporation, 3M Pharmaceuticals, Dell Computer Corporation, IVAC Corporation (Division of Eli Lilly), and Baxter Healthcare Corporation, Hyland Laboratories Division.

Our Consultants are trained by BIO -REG Principals and at selected training programs sponsored by professional organizations. Our affiliations include Regulatory Affairs Professional Society (RAPS), Association for the Advancement of Medical Instrumentation (AAMI), and American Society for Quality (ASQ).