As former managers at the Center for Veterinary Biologics (CVB), we have extensive experience in all regulatory issues for veterinary biologics (veterinary vaccines, antiserums, immunomodulators, antitoxins, and diagnostic test kits). The CVB consists of 2 sections, Policy, Evaluation, and Licensing (PEL) and Inspection and Compliance (IC). PEL is responsible for developing and implementing licensing policy, testing, and approval of licensing of veterinary biologics distributed within or from the U.S. IC is responsible for inspection and approval of facilities and production records, approval of release of serials of veterinary biologics, and compliance with USDA regulations. Together, we have expertise in both sections of CVB.
Dr. Henderson retired from the CVB as a manager in PEL in 2008 and has since been a consultant in veterinary biologics. She served as Chief of Biotechnology, Immunology, and Diagnostics. She was responsible for overseeing policy, laboratory testing, and review and approval of licensing submissions for all biotechnology, immunology, and diagnostic products. She also has expertise in regulatory jurisdiction issues for those products that may be either a veterinary biologic regulated by the USDA or a veterinary drug regulated by the FDA.
Dr. Lewis left the CVB as a manager in IC in 1994 and has since been a consultant in veterinary biologics. She has extensive experience and expertise in facilities inspection and requirements for licensing and permitting of veterinary biologics. She facilitated the Institute for International Cooperation in Animal Biologics (IICAB) Training from 1996-2014.
We each have 20 years or more experience with significant experience as managers in the Center for Veterinary Biologics. As a consulting firm, we provide guidance and advice regarding regulation and licensing of veterinary biologics. Together we have expertise in all aspects of veterinary biologics regulation with the exception of complex statistical analysis. We specialize in helping new firms that have limited experience in veterinary biologics regulatory issues and provide complete guidance toward licensing, permitting, post-license regulatory issues, facilities review, mock inspections and compliance post-licensing. In addition, we work with many established firms to develop compliance plans and resolve complicated regulatory issues.
Our goal is to provide guidance in efficiently meeting all USDA requirements for distribution of veterinary biologics in and from the U.S. We customize our services to meet each firm's specific needs and manage integration of our services so that the process is seamless for our clients.
We invite you to find out how we might help you efficiently comply with all USDA regulations on veterinary biologics.
Please contact us by e-mail at firstname.lastname@example.org.