150 Years of Combined Life Science Experience
Penny has 28 years of medical device experience in regulatory, clinical affairs, and quality systems (RAC, CQA) including direct interaction with FDA at federal and state levels in 8 different companies. She has prepared and closed over 100 regulatory submissions and registration/device approvals. Penny specializes in creative regulatory strategies to successfully navigate complex issues and achieve expedient product registrations.
Bill has 29 years of industrial experience in drug development, from early research projects to full commercialization. His understanding of total development process includes drug formulation, delivery, device testing, process development, technology transfer and manufacturing scale-up, quality control, clinical trial supply packaging, cold-chain distribution, regulatory, and toxicology. Bill has led the preparation of CMC sections of regulatory submissions for drugs, biologicals and devices, and served on numerous NIH grant and SBIR review panels.
Jeff is a seasoned expert with over 25 years of global medical device experience in product development, start-ups, turnarounds, bankruptcy, mergers/ acquisitions, business integration, process improvement, quality/regulatory and project management. Held numerous operational positions with Baxter Healthcare, C.R.Bard, InterVascular Inc., Horizon Medical Products, Graham-Field, Windstone Medical, Norwood EyeCare and Glenveigh Medical.