Randy J Prebula

Whether describing complex science in straightforward terms to lawyers or translating premarket and compliance regulatory requirements to scientists, Randy Prebula focuses on practical industry experience and a deep understanding of Food and Drug Administration (FDA) regulations to help clients navigate the intersections of science, policy, and law. By helping companies focus on both what they have done and why their approaches address patient and public health needs within their relevant regulatory processes, Randy seeks to promote public health by helping ensure that medical products are safe and effective.

Randy is a key resource for companies designing, developing, and producing healthcare products and treatments, including medical devices, drugs, biologics, human tissues, and combination products. He works seamlessly across borders with clients and internal teams to help bring innovative medical products to market, monitor their performance throughout their unique life cycles, and ensure their availability to help meet individual patient and public health needs.

Randy previously led our Medical Device and Technology Regulatory team and now helps develop and integrate legal and non-legal professionals to leverage their technical and legal knowledge to provide clients with practical, implementable solutions to meet their regulatory goals. He also helps companies with cutting-edge technologies navigate and optimize the FDA approval process.

Randy brings a wealth of experience in immunology, biochemistry, and new product development and provides real-world experience in developing, implementing, and maintaining compliant regulatory systems and procedures.