About EDGE Veterinary Vaccines Consulting Group, LLC
The mission of EDGE is to provide cutting edge regulatory support, product planning and development advice, and technical knowledge services leading toward the development, global registration, production, and distribution of veterinary vaccines and other veterinary biological products.
EDGE specializes in rapid delivery of services that draw on our broad experience. We provide assistance with all aspects of veterinary vaccine regulatory affairs ranging from company start up and initial product licensure to global distribution. In addition, we offer training, ranging from short overviews to on-site, in-depth programs and technical advice.
Our Specialties
- All aspects of veterinary vaccine regulatory affairs from company start-up to global expansion
- Development planning, study design, report generation, and agency discussions and meetings
- Veterinary vaccine training and development
- Problem solving related to R&D, manufacturing, QC, and more
- Preparation for agency facility inspections
- Advice and training for complying with Select Agent regulations
- Support in efforts to reduce animal usage (3R initiatives)
- Assistance in compliance with NCIE Import and Export requirements
- Assistance with emerging disease vaccine development and exotic disease vaccine banks
- Assistance with mergers and acquisitions
- Assistance in compliance with Department of Commerce Export Administration, Bureau of Industry and Security requirements
- Assistance in international harmonization
Consultants
Hans Draayer
Hans has devoted his entire career to the development and registration of veterinary biologicals. He has worked for major corporations including Pfizer Animal Health, SmithKline Beecham, and Beecham Laboratories, holding various senior regulatory and R&D management roles. Hans has developed and licensed vaccines for all major species with the USDA Center for Veterinary Biologics and other global regulatory agencies.
Donna Gatewood
Upon completion of her graduate work, Donna held leadership positions in the veterinary vaccine industry in Research & Development and in Regulatory Affairs. She left industry to join the USDA’s Center for Veterinary Biologics where she worked in the Policy Evaluation and Licensing Unit, first as a Senior Staff Reviewer and then as Section Leader for Virology. As a Section Leader, she was part of the CVB’s Expanded Management Team and participated the development of Center policy.
Larry Elsken
Larry has spent over 30 years in the testing, inspection, and licensing of veterinary biological products, primarily at the USDA Center for Veterinary Biologics. Special areas of interest are the licensing/permitting of new, emerging, foreign and transboundary disease vaccines; aquaculture products; manufacturing facilities inspection; and addressing compliance issues.
Carolyn Ross
Carolyn joined EDGE from Zoetis, Inc. After several years in R&D at Fort Dodge Animal Health, she moved to Regulatory Affairs to support new and existing biologics in the EU and US. Under Zoetis, she provided Regulatory Compliance support at a manufacturing site. She brings experience in quality systems, deviation reporting, and facility compliance management.
