Consulting Services

Our Mission

The Regulatory Science Consulting Center applies the expertise of its faculty, associates, and students to the regulatory challenges that face your medical product. We provide advice and services to faculty with new grants, start-up companies with interesting products, and anyone else who might need a little extra regulatory help.

How We Work

TALENT DIRECTED TO YOUR PRODUCT

The Regulatory Science Consulting Center focuses the expertise of its faculty, associates and students on regulatory challenges that face your medical products. We provide advice and services to faculty with new grants, start-up companies with interesting products, or others who just need a little extra regulatory help.

To start we will sit with you for an hour without any charge. If you decide we can help you, we can set up a project plan with you. This is particularly important if you are applying for a grant and need letters or text regarding our contributions. We will then identify experts and students according to your needs.

Who We Are

AN EXPERIENCED AND FOCUSED TEAM

Principals

Frances J. Richmond, Ph.D.

Photo of Frances J. Richmond and C. Benson KuoDr. Frances Richmond was educated as a neurophysiologist (BNSc, MSc, PhD) at Queen’s University (Kingston, Ontario). She completed post-doctoral studies at the Universite de Montreal and the National Institutes of Health before joining the faculty of Queen’s University, where she served as Associate Dean of Life Sciences (1986-1989). She also served as a policy advisor for scientific labor needs at Industry Canada (1990-1992) and as a clinical scientist at the Alfred E. Mann Foundation, an early stage device development group (1994-1995). She was the first female to be appointed Director of a research consortium funded by Canada’s Medical Research Council (1995-2000).

Dr. Richmond joined the faculty of USC in 1999 as Director of Regulatory and Clinical Sciences at the Alfred E. Mann Institute, with a joint appointment in the School of Pharmacy. Her current work includes seven projects in the field of product development which have advanced to the clinical trial stage. Though focused mostly on the BION, an implantable wireless microstimulator, she is also involved in research on other implantables, such as sensors and prosthetic limbs. Dr. Richmond is a member of two large research consortia (NIH Engineering Research partnership and NIH Bioengineering Research partnership) and is Director of the Regulatory Science program, which provides training in the regulatory management of foods, dietary supplements, medical devices and drugs.

C. Benson Kuo, Ph.D., RAC

Dr. C. Benson Kuo is the Associate Director of the Consulting Center. He acts as consultant for regulatory compliance, submission requirements, and strategic planning for innovative products developed at USC or by community members. Prior to joining the program, he served as the regulatory affairs manager at Alfred E. Mann Institute, responsible for regulatory support of medical device development and regulatory submissions and compliance with the FDA and IRBs.

Before embarking on his regulatory affairs career, he worked in biotech industry and served as bioinformatics scientist, patent scientist and patent agent.

Dr. Kuo completed his Ph.D. in the field of biomedical sciences and received postdoctoral training at the Stanford University School of Medicine. He is a graduate of the Regulatory Science program and RAC-certified by the Regulatory Affairs Professional Society (RAPS). He is a member of RAPS, OCRA (Orange County Regulatory Affairs Discussion Group), and the CSTA RK group (Clinical and Translational Science Award Regulatory Knowledge).

Nancy Smerkanich, DRSc, MS

Dr. Nancy Smerkanich is an Assistant Professor, Clinical Pharmacy, School of Pharmacy at the University of Southern California (USC).  She also serves as an Educational Liaison and Instructor, International Center for Regulatory Science.  Dr. Smerkanich recently completed her doctorate in Regulatory Science on the Implementation of Benefit-Risk Frameworks in Industry.  She leads the clinical regulatory courses while continuing to provide regulatory guidance to her academic and industry peers. In her role at USC, she brings many years of practical regulatory knowledge and experience to academia.  As the former (Executive) Vice President of Global Regulatory Affairs at Octagon Research Solutions, and a senior Consultant in Regulatory Affairs at Accenture, Dr. Smerkanich was responsible for advising sponsors on drug development, regulatory filing strategy and submissions.  Prior to her joining Octagon/Accenture Dr. Smerkanich worked as an independent consultant and as a Regulatory Coordinator at Merck.  With over 30 years of experience, Dr. Smerkanich has participated in all regulatory aspects of drug development, having served as Regulatory Liaison, US Agent, and Global Regulatory Lead across all therapeutic areas.