I have worked extensively with regulatory affairs in regard to filing and approvals for more than 30 years. My experience in corporate environments such as Eli Lily/CPI, Inc., C.R. Bard, Inc. and London International Group, plc, has given me great insight into what is expected beginning with the development of a product through filing, marketing and use.
I have shared my expertise with students at the University of Georgia for more than a decade, to develop professionals who understand how regulatory needs apply to business models. Serving as the director of the regulatory affairs graduate education programs since 2004, I helped develop the program’s strategic plan to meet the needs of science, medical device and pharmaceutical companies. Taking part in the recruitment of professionals to teach the program allowed me to select only those whose experience can best benefit our students and the future of the field.
I also am the principal consultant at Mullis and Associates. We are a regulatory affairs and clinic studies consulting firm supporting the medical devices and biotechnology industries. Since 1999 we have helped resolve regulatory compliance issues, obtained FDA Market Clearance for medical products and filed countless IDEs, INDs and PMAs with both domestic and international regulatory agencies.
In addition I serve on the serve on the Board of Directors for several companies and have assisted with resolving both Good Manufacturing Practices (GMP) and Good Clinical Practices (GCP) compliance issues with regulatory agencies. In 2013 I was one of only five selected to be a Fellow in the Regulatory Affairs Professional Society (RAPS).