is the division of the ERA Consulting Group that provides specialist
consulting services relating to biologics in the US. Our expertise
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
Tel.: 202 234 9378
Fax: 202 237 2172