U.S. Regulatory Strategy and Submissions

Entering the U.S. market requires navigating a regulatory system that is very different from Europe. JGS Group provides a complete regulatory roadmap to help European innovators secure market authorisation efficiently. We assess your product, identify the most appropriate FDA pathway (510(k), De Novo, PMA, IDE), and prepare and manage submissions directly with the U.S. Food and Drug Administration. We can act as your official U.S. FDA Agent and handle all communication with regulators. We also support quality system compliance (21 CFR 820), labeling and advertising reviews, and due diligence for investors and partners. Our goal is to provide a clear, reliable route into the U.S. market, avoiding costly missteps. FDA strategy development, representation with the FDA for submissions, FDA submissions and approval, FDA US Agent representation. Reimbursement analysis report which would include a strategy, a path to payment for the technology from insurance companies and Medicare. Clinical trial protocol development for FDA and for payers and industry. Identify and introduction to distribution partners for sales on the US market.