Biologics Consulting
Christina Vessely is a highly experienced Principal Consultant at Biologics Consulting, specializing in the development of therapeutic proteins, including peptides, monoclonal antibodies, and vaccines, with a focus on client support from early R&D through commercialization. Previous roles include Director of CMC/Regulatory Affairs at KBI Biopharma, where leadership was provided to a team on regulatory filings, and Associate Director at Merck, overseeing formulation development for therapeutic proteins. Earlier experience encompasses positions as a Formulation Scientist II at Insmed Therapeutic Proteins and a Scientist at FeRx Incorporated, as well as completing a PhD in Pharmaceutical Sciences at the University of Colorado Anschutz Medical Campus. Christina Vessely holds a B.S. in Chemical Engineering from the Colorado School of Mines.
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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.