My scientific expertise includes genetic engineering, design and development of human disease animal models, vaccine platform design, protein purification, and virology. I established GMP production for vaccine platforms and managed Quality Systems in drug manufacturing. I managed Regulatory and Clinical planning and execution for drugs, biologics and medical devices. I designed and managed ISO 13485 QMS, technical files, biocompatibility testing, and clinical evidence evaluations. I managed projects in product development, regulatory, clinical and Quality for biotechnology companies and medical device companies. Regulatory strategic planning, outreach, communication, and submission design and completion are a specialty. With PharmaJet my research and scientific knowledge, regulatory and clinical experience combined to help make significant contributions with needle-free injection technology for widespread vaccinations and the commercialization of DNA vaccines and therapeutics.