P.O. Box 50755
Eugene, OR 97405
Contact: Leonard Krause
FDA Connect, Inc. is a consulting company based in the Pacific Northwest offering electronic registration and product listing services to the FDA on behalf of homeopathic and OTC drug manufacturers and marketers. FDA Connect has developed a web based software solution that permits it to work collaboratively with clients to initiate and manage establishment registrations and product listings. This process eliminates the need for companies to navigate and use the limited software offered by the FDA. It ensures that their products are listed in a timely manner in compliance with FDA regulations, and permits them to manage each of their listings over a product’s lifecycle.
FDA Connect specializes in serving the homeopathic pharmaceutical industry, through its understanding of the complexities of homeopathic remedies with multiple strengths, changing formulations, and varied packagings that may be modified over time. The company’s clients range from large homeopathic manufacturers and contract manufacturing facilities to small producers and private label distributors.
The founder and president of FDA Connect, Inc., Leonard Krause, has more than twenty five years experience working in the field of government compliance and market research. He holds a Master’s degree in International Business and International Relations from the University of California, San Diego, with a focus on Political Science and government institutions. His first contact with the homeopathic industry came in the mid-1990’s when he was retained by a large European homeopathic manufacturer to research opportunities for its products in the US. Since then, he has continued to work with the homeopathic industry, and has acted in an advisory capacity in the public and private sectors on behalf of agricultural producers, state and federal government, natural resource producers, building products manufacturers, and the medical device industry.