Hogan Lovells 2024 Election Impact and Congressional Outlook Report
Alex Smith
Director of Regulatory Sciences Global Regulatory
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Overview
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Experience
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Credentials
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Insights and events
As a former process and software engineer at GlaxoSmithKline and Human Genome Sciences, Alex Smith understands the pressure medical device and pharmaceutical companies around the world face when working with the U.S. Food and Drug Administration (FDA) to resolve premarket and postmarket technical compliance concerns within the ISO/USP/QSR and cGMP frameworks.
Alex’s primary practice involves assisting companies with medical device and pharmaceutical submissions that involve software such as AI/ML submissions, Cybersecurity and 21 CFR Part 11 concerns. In addition to providing software services, Alex frequently works with companies around the world to avoid and respond to QSR and cGMP enforcement from FDA and Health Canada. Alex is RAC certified for FDA Drugs and Devices by the RAPS organization.
Credentials
Education
- Master of Business Administration, University of Maryland, 2013
- B.S. Computer Engineering, University of Maryland, 1999