Biologics Consulting

Biologics Consulting is a leading FDA regulatory and product development consulting firm in the biotechnology, healthcare, and pharmaceutical industries. Founded in 1993, the company has established itself as a go-to consulting partner for companies seeking to bring innovative products to market in the US. With a team of regulatory scientists, FDA consultants, and professional services staff, Biologics Consulting offers a unique combination of expertise across biologics, medical devices, pharmaceuticals, and biosimilars. The company's wide range of services includes regulatory and product development consulting, clinical planning, quality support, medical writing, e-publishing & submissions, US agent services, and due diligence. Its diverse client base spans established multinational pharmaceutical, biotechnology, and medical device companies, as well as academic and research institutions, and small biotech and medical device start-ups. In its three decades of operation, Biologics Consulting has served over 4,500 clients from 58 different countries. The firm's depth of knowledge and breadth of experience enable it to address clients' regulatory and product development challenges from preapproval to commercialization, setting it apart in the industry. With its headquarters in the United States, Biologics Consulting offers unparalleled insider perspective and expertise tailored to the specific needs of its clients.