Randy J. Prebula
Whether describing complex science in straightforward terms to lawyers or translating premarket and compliance regulatory requirements to scientists, Randy Prebula focuses practical experience and a deep understanding of FDA regulations to help clients navigate the intersections of science, policy, and law.
As a key resource for medical device, drug, human tissue, and combination product manufacturers, Randy works seamlessly with clients, internal teams, and across borders to help bring innovative medical products to market and meet patient needs throughout each product's unique life cycle.
He brings not only a wealth of experience in immunology, biochemistry, and new product development, but he also provides real-world experience in developing, implementing, and maintaining compliant regulatory systems and procedures.
Areas of Focus
Assisted Cohera, Inc. with PMA approval of novel tissue adhesive, TissuGlu.