#USA #Boston #FDA #Medicilon #R&D

Medicilon Achieves FDA Inspection Milestone

On May 20, 2025, Medicilon Preclinical Research (Shanghai) LLC, known simply as Medicilon, proudly announced its successful completion of an on-site inspection conducted by the FDA (U.S. Food and Drug Administration). This achievement is a significant milestone that reinforces Medicilon's reputation as a trusted leader in preclinical R&D services.

A Rigorous Evaluation of Compliance

The FDA inspection was thorough, examining various facets of Medicilon's operations. The evaluators scrutinized the company's organizational structure, the qualifications of its team members, standard operating procedures (SOPs), facility integrity, documentation processes, experimental operations, quality assurance systems, and IT infrastructure. Furthermore, several research projects submitted to the FDA were reviewed in detail.

Medicilon received praise from the FDA officials for its scientific discipline and operational excellence, expressing their eagerness to continue receiving high-quality data from the company. This commendation affirmed Medicilon's unwavering commitment to its guiding principle: “Quality First.”

A Strategic Validation for Global R&D Impact

This marks Medicilon’s first FDA inspection in seven years, and the successful outcome significantly bolsters the company's regulatory credibility. The milestone aligns perfectly with Medicilon’s innovative and quality-focused strategic vision. By the end of 2024, Medicilon had facilitated 520 Investigational New Drug (IND) applications to initiate clinical trials, backed by approvals from various regulatory bodies, including China's NMPA, the U.S. FDA, the European Medicines Agency (EMA), Australia's TGA, and South Korea's KFDA. Notably, these INDs comprise innovative drugs across different categories, including 34 antibodies, 28 antibody-drug conjugates (ADCs), 8 GLP-1 drugs, 6 PROTACs, and 3 botanical drugs, among others.

Looking ahead, Medicilon is committed to increasing its investment in technological innovation and R&D. The firm aims to launch even more innovative and higher-quality technological and service solutions, taking full advantage of the vast opportunities and challenges posed by the global pharmaceutical market. This commitment is set to drive the development of the global pharmaceutical industry as a whole.

About Medicilon

Founded in 2004, Shanghai Medicilon Inc. (stock code 688202.SH) has dedicated itself to providing comprehensive R&D services to pharmaceutical companies, research institutions, and organizations engaged in preclinical work. By late 2024, Medicilon had delivered drug development services to over 2,000 clients globally, significantly contributing to the development of 520 new drugs and generic drug projects, all of which have received IND approvals for clinical trials. Medicilon’s ongoing dedication to excellence and continuous improvement positions it firmly at the forefront of the biopharmaceutical field.

In conclusion, Medicilon’s recent inspection success is not just a reflection of compliance but a testament to its long-standing commitment to quality and innovation in the ever-evolving landscape of the pharmaceutical industry. As Medicilon moves forward, its focus on research and development will undoubtedly continue to advance both its goals and the global health landscape.