Biologics Consulting
Matthew Krueger is a Senior Consultant specializing in Medical Devices at Biologics Consulting, where expertise is applied in the development and implementation of regulatory strategies for both premarket and post-market compliance since April 2020. Prior to this role, significant experience was gained at the FDA from September 2004 to April 2020, including positions such as Assistant Director of Neurosurgical Devices, where oversight of a review team for regulatory compliance was provided. Additional roles at the FDA included Branch Chief of Compliance for various medical device categories and Biomedical Engineer focusing on both vascular and circulatory support devices as well as peripheral vascular devices. Matthew Krueger holds a Master of Engineering in Bioengineering and Biomedical Engineering from the University of Pennsylvania and a Bachelor of Engineering in Mechanical Engineering from Southern Methodist University.
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Biologics Consulting
ABOUT Biologics Consulting is a complete FDA regulatory and product development consulting firm for cell & gene therapy, biologics, pharmaceuticals, and medical devices. In the nearly three decades since its founding, Biologics Consulting has become the go-to consulting partner for companies large and small seeking to bring innovative, safe, and effective products to market in the US. Our team of consultants and professional services staff is comprised of subject-matter experts with decades of industry and/or FDA experience that allows us to provide an unparalleled insider perspective. OUR DIFFERENCE The Biologics Consulting difference is all about the unique combination of expertise we have under one roof. Our team has depth of knowledge and breadth of experience across all product types and development pathways. This value proposition allows us to address the full scope of a client’s regulatory and product development challenges. OUR EXPERIENCE AREAS - Biologics - Medical Devices - Pharmaceuticals - Biosimilars OUR SERVICES - CONSULTING – Regulatory, Product Development, Clinical Planning and Quality support. - SUPPORT SERVICES – Medical Writing, ePublishing & Submissions, US Agent Services, Due Diligence OUR CLIENTS Our clients span the industry, from established multi-national pharmaceutical, biotechnology, and medical device companies to academic and research institutions. We also support small biotech and medical device start-ups. Since our founding, we have professionally services over 4,500 clients from 58 different countries.