Expertise:
Dr. Ma's expertise includes neurosurgery and pharmaceutical products, medical device development, commercialization facilitation, and the oversight of import and export issues such as distribution, sales and marketing.
Major Product/SVS:
Consulting Services Including Comprehensive Regulatory Compliance, Quality Assurance and Business Development Services, Strategic Planning, Effective Market Research and Business Relationship Facilitation, Due Diligence, Technical Transfer, Validations, Pre- and Clinical Product Developments, Regulatory Services, Quality Control
Favorite Business Publication:
Fortune; BusinessWeek
Education Degrees:
Doctor of Medical Sciences, Tokyo University, Japan (1988); MD, Capital University of Medical Sciences, Beijing (1983); Ph.D., Rutgers University, The State University of New Jersey
Affiliations Awards:
Generic Pharmaceutical Association; American Association of Neurological Surgeons; Congress of Neurological Surgeons; Association of American Physicians and Surgeons; American Association for Cancer Research; Society of Army Physician Assistants; Drug Information Association
Work History:
Founder, President, Chief Executive Officer, Medical Quality International; Senior Management, Johnson & Johnson; Senior Management, Cell Pathways; Senior Management, Gliatech Medical; Senior Management, Various Pharmaceutical, Biotech and Medical Device Companies
Number Of Years In Profession:
26
Extended Bio Profile:
Dr. Ma had 14 new drugs, and seven medical devices developed and approved by the United States Food and Drug Administration under his direction. In the past five years, Dr. Ma has been leading the motion of creating and facilitating the development and commercialization of pharmaceutical and medical device products in the United States and China for companies in the United States. At the same time, they offer these services to United States pharmaceutical companies, including generic organizations outsourcing their needs for pharmaceutical ingredients. Dr. Ma also successfully reversed a severe warning letter from the Food and Drug Administration to an API manufacturer within six months. In addition, he in-licensed two molecular diagnostic technologies from a United States biotechnological company and co-founded a manufacturer for diagnostic products on HIV and herpes.
Position Responsibilities and Duties:
Working as a Results Oriented Leader in the Areas of Clinical, Medical, Regulatory, Quality Assurance, and Business Development for Drug, Medical Device and Biomedical Product Developments, Offering Expert Services in Medical, Biotech and Pharmaceutical Arenas within Regulatory Agencies, Organizations and Pharmaceutical, Biotech, and Medical Device Societies in the United States, Europe, Japan, and China, Filing Regulatory Requirements for United States Food and Drug Administration Approvals, Utilizing his Experience with Pharmaceutical, Biomedical, and Medical Device Development in Multidisciplinary Areas with a Concentration in Areas Including Oncology, Central Nervous System, Anti-Inflammatory and Topical Delivery Control Release Dose Form
Education Certifications:
Certified Attending Physician of Neurosurgery