Medicilon Successfully Completes FDA Inspection, Solidifying R&D Leadership

Medicilon's FDA Inspection Success



On May 20, Medicilon Preclinical Research (Shanghai) LLC announced a significant milestone by successfully completing an inspection conducted by the U.S. Food and Drug Administration (FDA). This inspection marks a crucial endorsement of Medicilon's strong position as a trusted leader in preclinical research and development services on a global scale.

A Thorough Examination of Capabilities



The FDA inspection was carried out meticulously, assessing various critical aspects of Medicilon’s operations. Inspectors evaluated:

  • - Organizational Structure: The hierarchy and roles within the company were analyzed to ensure optimal functionality.
  • - Personnel Qualifications: Ensuring that the staff members possess the necessary expertise and skills for conducting high-quality research.
  • - Standard Operating Procedures: A review of the documented processes that guide research and operational practices.
  • - Facility Status: Assessing the technical condition of the facilities to confirm they meet regulatory standards.
  • - Documentation Processes: Evaluating how projects and data are documented throughout their lifecycle.
  • - Execution of Experiments: Observing how experiments are conducted to ensure scientific integrity.
  • - Quality Assurance Systems: Comprehensive checks on the quality assurance measures in place to maintain high standards.
  • - Computer Infrastructure: Scrutiny of the IT systems supporting research activities.

Additionally, the FDA team examined several research projects submitted for review, confirming the company's capabilities in delivering reliable data.

Recognition of Excellence



During their assessment, FDA representatives praised Medicilon's scientific precision and operational excellence, expressing their anticipation for future high-quality data submissions. This acknowledgment serves as a testament to Medicilon's unwavering commitment to its motto: “Quality First.”

Strategic Importance of the Inspection



This inspection was the first conducted by the FDA at Medicilon in seven years. Successfully passing it significantly enhances the company’s regulatory credibility. This key milestone reaffirms Medicilon’s strategic vision, which champions “Innovation as Engine, Quality as Foundation.”

By the end of 2024, Medicilon expects to have aided over 520 clinical trial applications to enter the clinical phase, assisted by approvals from key regulatory bodies including the Chinese National Medical Products Administration (NMPA), the FDA, the European Medicines Agency (EMA), and others. These applications represent a diverse array of innovative therapies, including 34 monoclonal antibodies, 28 conjugated antibodies, and several other groundbreaking treatments.

Commitment to Innovation



Looking toward the future, Medicilon is steadfast in its commitment to increasing investments in technological innovation and research development. The company is determined to introduce more innovative and high-quality technology and service solutions, addressing opportunities and challenges in the global pharmaceutical market while fostering the continued growth of the pharmaceutical industry worldwide.

About Medicilon



Founded in 2004, Shanghai Medicilon Inc. (stock code 688202.SH) has dedicated itself to providing comprehensive R&D services to pharmaceutical companies and research institutions engaged in preclinical studies. By the end of 2024, Medicilon has serviced over 2000 global clients and contributed to the development of 520 novel drugs and generics approved for clinical evaluation.

Topics Health)

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