Consulting Continuum
From Ideas to Regulation
The Kim Center, in partnership with the Department of Regulatory and Quality Sciences, offers extensive consulting services to meet diverse needs across the medical product development lifecycle, spanning from ideation to regulation. These services are facilitated through three distinct consulting streams: the Translational Regulatory Consulting Services, Team-Based Regulatory and Quality Solutions and the Regulator’s Solution Network.
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Translational Regulatory Consulting Services aids academic investigators, faculty with new grants, and small innovative initiatives by offering expertise in various areas. Services include support for investigational new drugs in pharmaceuticals and biologics, study protocol development, medical device premarket notification, establishment of medical device quality systems, 510k submissions, orphan drug designations, and repurposed drugs. Students pursuing PharmD or Masters degrees at DRQS are encouraged to participate in the Center’s operations under the guidance of faculty and staff.
For more information on the Translational Regulatory Consulting Services, email Benson Kuo at chiaoyuk@usc.edu. -
Team-Based Regulatory and Quality Solutions (TRAQS) leverages the collective expertise of an interdisciplinary team of students, overseen by faculty, to address real-world projects sponsored industry. Previous projects have included a range of critical areas, such as regulatory strategy for product licensure, clinical research and commercialization strategies, clinical trial design, market launch strategy, competitive analysis, reimbursement strategy, quality system gap analysis, and validation master plans and protocols.
For more information on TRAQS, email Susan Bain at bain@usc.edu. -
Regulator's Solution Network serves as a hub catering to the research needs of both medical and device regulators. Faculty, staff, and students from DRQS's Masters, PharmD, or DRSc programs collaborate to develop tailored solutions in capacity building, regulatory assessment, and process optimization. Through a robust training program, the Network seamlessly integrates scientific advice into developmental initiatives while providing educational support and fostering collaborative research, enhancing regulatory practices.
For more information on Regulator's Solution Network, email Lawrence Liberti at liberti@usc.edu.
Our Team
Susan Bain, DRSc
- Assistant Professor of Regulatory and Quality Sciences
Accomplished quality and regulatory professional with experience in the medical device and pharmaceutical industries
Nancy Pire-Smerkanich, DRSc, MS
- Assistant Professor of Regulatory and Quality Sciences
Professional who brings 30 years of industry experience in drug development to academia
Lawrence Liberti, PhD
- Associate Professor of Regulatory and Quality Sciences and Director of the D.K. Kim International Center for Regulatory Science
Bringing a wealth of experience from academia and industry, with a particular emphasis on international regulatory policies, he underscores his profound understanding of global regulatory frameworks.
Frances J. Richmond, PhD
- Professor Emerita of Regulatory and Quality Sciences
An expert in implantable medical devices, clinical trial regulatory issues, and regulation of pharmaceuticals and medical device products.
Eunjoo Pacifici, PharmD, PhD
- Chair & Associate Professor of the Department of Regulatory and Quality Sciences
Eunjoo Pacifici is an expert in drug regulations, the global pharmaceutical market, and international medical product regulations.
C. Benson Kuo, PhD
- Assistant Professor
C. Benson Kuo's research focuses on regulatory issues for innovative medical products and product safety in Asia.