Biologics Consulting
Ellen Raaf, MT, ASCP is a seasoned professional with extensive experience in the biopharmaceutical and quality management sectors. Currently serving as a Senior Consultant at Biologics Consulting Group since 2007, Ellen has previously held key positions including Quality Manager at Biolex and Quality Systems Manager at Bayer/Talecris. Earlier career roles include Manager of BioAnalytical Methods Development at Alphavax, Senior Scientist at Covance, and various supervisory and development positions at Wyeth. Ellen began the career as a Medical Technologist/Biochemist at GlaxoSmithKline. Academic credentials include a Bachelor of Science in Microbiology and Medical Technology from Penn State University, supplemented by training from the US Army Medical Service Corps Officer Basic Course.
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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.