REGULATORY STRATEGIES, INC.
MARK D. KRAMER
MEDICAL PRODUCT REGULATORY CONSULTING
RSI helps companies navigate the increasingly complex global regulatory environment for medical devices, pharmaceuticals, and combination products. Mark's extensive knowledge of the healthcare products industry, combined with over 17 years in key roles at the US Food and Drug Administration, provide unique insights that yield effective regulatory strategies.
Through a careful examination of your goals and the relevant regulatory requirements and precedents, we will help you formulate effective regulatory strategies and prepare regulatory submissions that address your desired indications and claims, target markets, regulatory pathways, and time frames.