Shanghai, May 20, 2025 – Medicilon Preclinical Research (Shanghai) LLC (“Medicilon”) announces that it has successfully passed an on-site inspection by the FDA. The company receives an official Establishment Inspection Report (EIR) reaffirming its position as a trusted leader in preclinical R&D services.

A Milestone of Compliance and Capability

The FDA inspection, conducted with meticulous detail, evaluated Medicilon’s organizational structure, personnel qualifications, SOPs, facilities integrity, documentation processes, experimental operations, quality assurance systems, and computerized infrastructures. Inspectors also reviewed several research projects submitted to the FDA.

FDA officials praised Medicilon for its scientific discipline and operational excellence, expressing anticipation for continued high-quality data submissions. This endorsement validated Medicilon’s enduring commitment to its guiding philosophy of “Quality First.”

Strategic Validation of Global R&D Impact

This is Medicilon’s first on-site FDA inspection in seven years, and the successful outcome significantly enhances its regulatory credibility. The milestone is a strong endorsement of its strategic vision, rooted in being “Innovation Driven, Quality Focused.”

Looking ahead, Medicilon is set to deepen its R&D investments, driving innovative, high-quality solutions that contribute to the global pharmaceutical landscape.