Regulatory and clinical strategy for the US market

Purpose and goal

The purpose of our initiative is to ensure that we have a robust regulatory strategy for the U.S. market that reflects recent changes, such as those in LDT/CLIA. By combining our internal expertise with external specialists, we aim to develop a regulatory strategy that meets all relevant requirements for the North American market. The goal is to establish a competitive position by quickly and efficiently adapting to the evolving regulatory context.

Expected effects and result

By strengthening our regulatory strategy with both internal and external expertise, we expect to effectively navigate the rapidly changing regulatory environment in the U.S. The result will be a well-founded and updated strategy that ensures we meet all relevant requirements. The effects of this work will be increased competitiveness and faster market adaptation, which in turn will lead to better long-term success in the North American market.

Planned approach and implementation

The project begins with a gap analysis compared to the previously completed IVD-CE work. With management directly involved and a broad base of regulatory, clinical, and quality expertise, the consultant´s expertise will be integrated into Reccan´s strategy and regulatory plan. The consultant´s role also includes updating the management´s knowledge of the current regulations for a U.S. launch and their specific implications for Reccan.