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A member company of the
ERA Consulting Group

US-BRS is the division of the ERA Consulting Group that provides specialist regulatory consulting services relating to biologics in the US. Our expertise covers, particularly, products of recombinant DNA technology and other protein therapeutics, vaccines, gene and cell therapy products.

Our clients range for biotech start-ups to large pharma, and our qualified and competent consulting team covers CMC, pre-clinical and clinical product development issues as well as regulatory affairs. We also undertake FDA submissions and provide US Agent services for non-US-based client companies.

The US-BRS website is currently under construction, but please do not hesitate to contact us. We will be pleased to respond with specific information and details of our consulting organization.

US Biologic Regulatory Services, LLC

741 3rd Street, NE

Washington, DC

Tel.: 202 234 9378

Fax: 202 237 2172