The Wood Burditt Group provides counsel to the biologics industry, including large and small manufacturers and trade associations. We assist in all matters related to FDA’s Center for Biologics Evaluation and Research (CBER).

We advise clients in numerous areas including: clinical investigator information, adverse event reporting procedures, compliance and surveillance, product development and application submission requirements, imports and exports, and Investigational New Drug Applications (IND) to administer an investigational product to humans.

Our clients specialize in cutting-edge biomedical research and produce numerous biological products, including blood, vaccines, allergenics, tissues, and cellular and gene therapies.