Leonard Baum Regulatory Solutions, LLC provides customized consulting services in regulatory affairs, product development, strategy, and issues resolution as well as submisisons, and labeling covering Rx, OTC, CBD, dietary supplements and Rx to OTC switch programs. The organization draws from over 40 years experience and expertise with FDA meetings, submissions, presentations, labeling and claims, M&A and product license activities, including due diligence and integration.Leonard (Len) Baum, RPh, is an industry leader with over 40 years of business and global product development and regulatory affairs experience covering a broad range of prescription and over-the counter (OTC) therapeutic and diagnostic imaging drugs, nutritionals and biologics. His experience and expertise includes strategic planning and processing of INDs, NDAs, BLAs, Rx to OTC switch and monographs and in launching new products with competitive labeling and advertising claims. He is an accomplished speaker and has made multiple presentations to Heath Authorities, Advisory Committees, industry trade meetings and Expert Ad Boards, and has conducted many product safety reviews. Len also has broad experience in conducting and managing activities related to mergers & acquisitions, due diligence, and product licensing activities. He has been recognized for his leadership and success in building, training and leading high performance teams across International sites, including the US, Canada, EU, and Japan, and has served as VP Regulatory Affairs (RA) for Bayer Healthcare Consumer Care, VP Global RA for Aventis Behring, President and COO Advanced Magnetics, as well as in regulatory positions with Bristol Meyers Squibb/Squibb Diagnostics, Hoechst-Roussel and Parke-Davis/Warner Lambert. He has also helped shape the regulatory environment through a history of appointments and volunteering on industry and professional committees and maintians a good working relationship with FDA along with a network of other consultants.