Biologics Consulting
Joshua Crist is a Principal at Biologics Consulting, specializing in regulatory strategy for medical devices and combination products, including a wide range of technology such as AI, digital health, and biosurgery devices. Prior experience includes serving as a Leader Review and Biomedical Engineer at the FDA, where Joshua led the review of complex medical devices and contributed to innovative initiatives and guidance documents. Joshua's background encompasses significant research at The Johns Hopkins University, focusing on tissue engineering and biomedical design, with multiple publications and successful projects that demonstrate a strong foundation in product development and regulatory compliance. Joshua holds both M.S.E. and B.S. degrees in Biomedical Engineering from The Johns Hopkins 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.