ABOUT Biologics Consulting is a complete 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 the unique combination of expertise we have under one roof. Our team brings a depth of knowledge and breadth of experience across product types and development pathways, allowing us to address the full scope of a client’s regulatory and product development needs. OUR EXPERIENCE AREAS - Biologics - Medical Devices - Pharmaceuticals - Biosimilars OUR SERVICES - CONSULTING – Regulatory, Product Development, Clinical Trials Planning and Oversight - 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 to small biotech and medical device start-ups. Since our founding, we have professionally services over 3,500 clients from 53 different countries.