JNP Medi announced on the 2nd that it will establish the ‘FDA Expert Solution,’ a comprehensive consulting service for obtaining approval of clinical trial plans and new drug applications from the U.S. Food and Drug Administration (FDA).
The FDA Expert Solution aims to provide end-to-end services supporting the entire communication process with the FDA, including preparation of clinical and non-clinical data, document drafting, clinical trial management, and regulatory strategy development. It plans to comprehensively support domestic pharmaceutical and biotech companies in achieving swift and efficient FDA approval, entering the U.S. market, and generating results in the global market. Additionally, the dedicated team will offer on-demand solutions that respond to all business stages, eliminating the need for companies to find individual vendors for each process, thereby significantly reducing time and costs.
JNP Medi has assigned a large number of professionals with U.S. qualifications and extensive experience?including Chief Medical Officers (CMOs), pharmacists, doctors, and lawyers?to the FDA Expert Solution team. Since the solution was planned based on an accurate understanding of U.S. regulatory procedures, the company also intends to pursue global partnerships and establish systematic market entry strategies. Furthermore, it is expected to create new revenue streams linked to its various solutions, such as the JNP Medi Partners program, which supports global licensing partnerships and investments.
Jung Kwon-ho, CEO of JNP Medi, stated, “FDA approval is an indispensable procedure for successful entry into the U.S. market and a very important process directly connected to the growth of pharmaceutical and biotech companies. We will develop a variety of comprehensive consulting services, led by the FDA Expert Solution introduced to fully support global market entry beyond the U.S., to back the new challenges of domestic companies.”
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