On May 20, Medicilon Preclinical Research (Shanghai) LLC (“Medicilon”) received an official letter and Establishment Inspection Report (EIR) from the FDA. The report indicates that Medicilon has successfully passed the FDA inspection. This milestone achievement not only reaffirms Medicilon’s excellence as a one-stop preclinical R&D service platform but also highlights its professional expertise and global influence.

FDA Inspection Success: A Commitment to Quality

During the inspection, FDA auditors conducted a comprehensive review of Medicilon’s organizational structure, personnel qualifications, SOPs, facilities, documentation, experimental processes, quality assurance systems, and computerized systems. Additionally, the auditors traced and reviewed multiple research projects submitted to the FDA.

The FDA inspectors highly praised Medicilon for its efficiency and rigorous scientific approach, expressing their anticipation for receiving more high-quality research data in the future. This successful inspection is the best interpretation to Medicilon’s long-standing commitment to “Quality First.”

Passing the FDA on-site inspection after seven years not only adds valuable credibility to Medicilon’s FDA compliance record but also serves as a strong endorsement of the company’s commitment to “Innovation Driven, Quality Focused.” Looking ahead, Medicilon will continue investing in R&D to deliver innovative solutions and contribute to the global pharmaceutical industry.

About Medicilon

From its inception in 2004, Shanghai Medicilon Inc. (stock code: 688202.SH) has been committed to providing comprehensive R&D services to pharmaceutical companies, research institutions, and any organizations working in the preclinical space. By the end of 2024, Medicilon has provided drug development services to over 2,000 clients worldwide, and has been involved in the research and development of 520 new drugs and generic drug projects that have been approved for clinical trials with IND applications.