Dr. Karen M. Becker is the founder and Chief Executive Officer of Becker & Associates Consulting, Inc., and Becker Venture Services Group, LLC. She has over 20 years of experience providing strategic scientific and FDA regulatory consulting services to clients developing innovative healthcare products. Clients include multi-national pharmaceutical and medical device companies, as well as mid-size and privately-held firms, their counsel, and investors. Services provided to clients include due diligence for acquisitions and investments, product development plans, FDA regulatory strategies, negotiations, and submissions, and compliance with FDA Quality System Regulations and current Good Manufacturing Practices.

The firm has experience in a broad range of therapeutic areas for both pharmaceuticals and medical devices, and is recognized as the leader in developing successful FDA strategies and appeals for approval and clearance of innovative products. The company is often called upon to manage FDA Advisory Committee meetings for clients, and directed each of the four Medical Devices Dispute Resolution Panels convened by FDA. Evaluation of post-marketing safety information and international manufacturing compliance issues are also well-recognized strengths of the firm.

Dr. Becker is the editor of the textbook “Clinical Trials of Medical Devices. Principles and Practices” and has written extensively on the regulation of FDA products. She received a BS in Biological Chemistry (University of Maryland, College Park) and a PhD in Pharmacology (University of North Carolina, School of Medicine). She is an adjunct Professor at Georgetown University McDonough School of Business