Randy J. Prebula

Randy J. Prebula

Partner Global Regulatory

Washington, D.C.

+1 202 637 6548

[email protected]

Languages

English, Spanish

Randy J. Prebula

Overview
Experience
Credentials
Insights and events

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 pulic 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. Randy works seamlessly across borders with clients and internal teams to help bring innovative medical products to market, monitor their performance throughoiut their unique life cycles, and ensure their availability to help meet individual patient and public health needs.

As director of the firm's FDA Medical Device & Technology practice area, Randy 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.

He 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.

Representative experience

Assisted Cohera Inc. with premarket approval (PMA) of novel tissue adhesive, TissuGlu.

Successfully advocated the FDA's downclassification of an imaging device, tissue culture media products, and in vitro diagnostic systems, avoiding the need for a PMA.

Assisted a company with FDA regulation and U.S. marketing authorization for veterinary wound care products.

Assisted a biotechnology company with evaluating FDA regulatory requirements for stem cell and regenerative medicine products and medical device sales and distribution projects.

Assisted clients with Tissue Reference Group advisory opinion requests and Office of Combination Product Requests for Designation (RFD).

Assisted clients with cell sorter and isolation systems, mesenchymal cells of multiple tissue origins for use, and products intended for reproductive technology applications.