Brief Biographies of Consultants
Ms. Toshiko Boyd, MBA, Managing Director
Ms. Boyd is a co-founder of Eureka Global Solutions (EGS) and brings 25 years of international business experience to our team. She provides overall strategic guidance for EGS and is also in charge of the healthcare sector, particularly in the areas of FDA application and registration. She has broad experience in preparation of applications and obtaining approval of medical devices, x-ray machines, food, food contact materials and veterinary products. She also has been instrumental in supporting clients' expansion of business between the U.S. and Japan across various industries.
As Vice President of corporate banking division at a large Japanese bank in Los Angeles, she has extensive experience in marketing, credit analysis and M&A transactions. Her focus was Fortune 500 companies on the West Coast in a wide range of industries including the healthcare sector. Prior to that, Ms. Boyd was a Senior Equity Analyst at both American and British securities companies in Tokyo where she was responsible for industry and company analysis and marketing covering a wide range of industries.
Ms. Boyd received an MBA majoring in Finance and Management from the University of Southern California and holds a BA in Economics and Public Finance from Keio University in Japan.
Ms. Irene Gomez
Senior Regulatory Advisor with work experience of over 32 years at FDA. While working at the FDA, she trained inspectors for both import goods and U.S. products for number of years. She was in charge of issuing enforcement notifications and recalls at the Los Angeles and Long Beach ports. She was also in charge of lectures to industry groups on FDA policy and regulations as a spoke person. After being the Director of the Los Angeles port, she retired from the FDA. She plays an active role at Eureka Global Solutions advising clients her hands-on experience and network of contacts within the FDA.
Dr. Peter Louie, MBA, Vice President & Senior Strategic Consultant
Dr. Louie has over 20 years of experience in various functional areas in the life science industry, including R&D, Operations, and Sales & Marketing. His industry experience includes planning, launching, and marketing of innovative products for diagnostic and instrumentation. His consultancy has focused on business strategic development, operations planning, market research, and cost reduction for clients in the life science, and other consumer health related industries.
Dr. Louie holds PhD in Biochemistry from University of California, Riverside and B.S., in Biochemistry, University of California, Davis and MBA in Finance from Pepperdine University.
Dr. Imke Schroeder, Senior Scientific Advisor
Dr. Schroeder has been a professor and a researcher of Department of Microbiology, Immunology and Molecular Genetics at UCLA since 1993. She is from Germany and earned a Ph.D. in Microbiology at Philipp University in Marburg, Germany in 1983. Dr. Schroeder also conducts extensive research on laboratory safety, with research centering on the bridge between state safety regulations and implementation of best practices in research laboratories. Furthermore, she coordinates seed grants funded by the Center for Laboratory Safety that aim to improve existing safety measures and/or develop new and safer laboratory methods.
As Senior Scientific Advisor, Dr. Schroeder is in charge of scientific review on FDA related projects and consulting.
Dr. Eri Oshima, Senior Scientific Advisor
Dr. Oshima earned her Medical Doctor (M.D.) degree at Albany Medical College in New York. She later entered the pharmaceutical industry and participated in new drug development and clinical trials management at a Southern California Biopharma company. She subsequently graduated from the University of Southern California's Pharmacy School Regulatory Science Master's Program (M.Sc.). She authored a chapter on edible seaweed and its use in traditional medicine for the Royal Society of Chemistry publication, "Traditional Chinese Medicine, Scientific Basis of Its Use" (2013). Dr. Oshima also completed a certification in Hazard Analysis & Critical Control Points ("HACCP") for seafood processing.
As a consultant, she has worked with global health food and dietary supplement product companies, providing solutions for building strong scientific evidence to support health claims. At Eureka Global Solutions, she brings expertise in medical and food products, as well as federal & state regulations, to the completion of various projects. Dr. Oshima regularly participates in seminars and conferences in the Medical Products industry and Regulatory, Academia, and Medical fields. She provides insights learned from field authorities and contributes reports in both English and Japanese on U.S. and Global Regulatory trends.
Eriko Ono, MS, Consultant
Ms. Ono was employed with the Ministry of Land, Infrastructure, Transport and Tourism of Japan for 13 years. She was in charge of policy planning and international projects in the transportation field. Ms. Ono also participated in numerous international negotiations for setting international standards, including the United Nations Climate Change conference ("COP"), and International Maritime Organization ("IMO"), which is a specialized agency of the United Nations. Leveraging on these experiences, Ms. Ono's consulting work centers on regulatory related research, project planning and project management.
Ms. Ono is a graduate of Mechanical Engineering from the University of Tokyo and received her master's degree in Technology Policy from Massachusetts Institute of Technology (MIT).
Mr. John Bradley, CPA, MBA, Senior Consultant - International Business
Mr. Bradley brings 25 years of international business and consulting experience to our team. He has worked in finance and business development roles in a variety of industries both in the U.S and Japan, including international banking, manufacturing and entertainment.
Mr. Bradley received an MBA majoring in International Business from the University of South Carolina and attended Cornell University and Keio University for the study of Japanese language. He also holds a CPA certification.
Mr. Bradley is in charge of advising and consulting on international business and finance.
Mr. Hiroharu Tsunoda, Senior Consultant
Mr. Tsunoda started his career in the sales and marketing of chemical products at a major trading firm and subsequently had long-term successful experience in establishment of overseas factories and management for small and medium-sized manufacturing companies in the United States and China.
Currently, as the president of NC Network, America, he supports manufacturing companies from various aspects, including advice on new technology, selection of suppliers and the development of next generation components. In our company, he advises our clients on medical device manufacturing for new technology, selection of suppliers, prototype products and components suppliers for mass production of medical devices. Mr. Tsunoda graduated from the Economics department of Keio University.
We also have the following consultants:
Senior Regulatory Consultant that has worked in a variety of therapeutic areas and research settings over the past 30 years including the laboratory, field, hospital, and clinic. She attended UCLA as an undergraduate, California State University, Northridge for her master's degree in Health Science/Epidemiology, and Yale University for her Ph.D. in Epidemiology and Public Health. She has managed over 100 clinical studies, which included monitoring for compliance with FDA regulations and Good Clinical Practices. She currently works at UCLA and responsible for ethics and compliance in research studies conducted at the David Geffen School of Medicine at UCLA.
In addition to the main consultants above, our company works closely with medical doctors, a medical device mechanical engineer, an FDA specialized lawyer, USDA specialized lawyer, a U.S. Patent and Trademark lawyer, an international business lawyer with legal qualifications from both Japan and the U.S. With the cooperation of such experts, we provide consistently high quality services to all of our customers.