I have 39 years of experience, and specialize in the field of Federal Drug Administration (FDA) regulatory affairs and quality assurance compliance with specific knowledge in the areas of medical devices, pharmaceuticals and foods. I have published on such topics as FDA compliance issues, dealing with the FDA and importing products to the USA. I have testified 7 times on topics such as quality systems registrarsâ€™ compliance issues, FDA submissions and regulatory problems and concerns. I have worked with companies worldwide and have visited over 1000 companies in the 38 years in this area. Have been an invited guest lecturer and worked with the governments of China, Taiwan, Thailand and Brazil.