Our Approach
Laurie Norwood is president of Norwood Biologics Consulting LLC, a consulting firm providing regulatory expertise in the manufacture of biological products. Prior to starting Norwood Biologics Consulting LLC, Ms. Norwood served 33 years at the FDA. During her last 13 years at the FDA, Ms. Norwood was Deputy Director for the Division of Manufacturing and Product Quality (DMPQ) in the Office of Compliance and Biologics Quality, Center for Biologics Evaluation and Research (CBE). Her years at CBER prior to 2006 included review work and also management of regulatory reviewers involved in the evaluation of Investigational new Drug applications (INDs), license applications and supplements for emerging Cellular and Gene Therapy products, viral vaccines, hematologic recombinants, in vitro diagnostic kits and blood fractionation products, as well as inspection of biological manufacturing facilities. During her early years at CBER she served as a scientist in a CBER research and development lab for nine years, receiving two patents for her work on in vitro potency testing for Oral Polio Virus Vaccine. Throughout her FDA career she was involved in policy and development of guidance documents related to the review and inspection of products regulated by the FDA.
Additional details can be provided in Laurie’s Curriculum Vitae (CV) upon request.