Quality Control

  • Leadgene Biomedical Inc. has a strong commitment to providing high-quality products and services to its customers, and to ensure compliance with its quality management system while continuously improving it. The company has established a rigorous quality management system in accordance with ISO 13485:2016 certification and QMS/GMP guidance. The entire production process of Leadgene's products, including recombinant proteins, enzymes, antibodies, kits, and other products, has been systematically managed and standardized through this third-party audited and controlled process.

    Leadgene's quality policy is centered on the customer's needs and statutory requirements in the targeted field. Leadgene launched its GMP-grade products that are produced in a pharmaceutical-grade manufacturing plant and designed under domestic and international regulations for cell and gene therapy to ensure the products are safe and effective.