Biologics Consulting
Donna-Bea Tillman is a seasoned principal consultant and device team leader at Biologics Consulting, where responsibilities include advising clients on regulatory requirements for medical software and developing preclinical testing strategies. Prior experience includes serving as Director of Regulations and Policy at Microsoft, managing submissions and postmarket safety programs, and holding various leadership roles at the FDA, culminating in Director of the Office of Device Evaluation with oversight of premarket reviews for medical devices. Earlier roles involved standard development at the US Consumer Product Safety Commission and biomedical software development at Johns Hopkins School of Medicine. Educational qualifications include a Ph.D. in Biomedical Engineering from The Johns Hopkins University, an MPA from American University, and a BSE in Bioengineering from Tulane 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.