About Biologics Consulting

Biologics Consulting is a complete FDA regulatory and product development consulting firm for cell & gene therapy, biologics, pharmaceuticals, and medical devices. In the 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 regulatory scientists, FDA consultants, and professional services staff has decades of industry and FDA experience that allows us to provide an unparalleled insider perspective for our clients.

OUR DIFFERENCE

The Biologics Consulting difference is all about the unique combination of regulatory 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 from preapproval to commercialization.

OUR EXPERIENCE AREAS

• Biologics
• Medical Devices
• Pharmaceuticals
• Biosimilars

OUR SERVICES

• CONSULTING – Regulatory, Product Development, Clinical Planning and Quality support.
• SUPPORT SERVICES – Medical Writing, e-Publishing & 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.