Recently, Medicilon successfully passed the rigorous qualification review and assessment by the China National Accreditation Service for Conformity Assessment (CNAS). Medicilon was awarded the CNAS accreditation certificate for national laboratories (Certificate No.: CNAS L21572), marking the official entry of Medicilon's Analytical Testing Center into the ranks of nationally accredited laboratories. This achievement signifies that its quality management system, hardware and software facilities, and testing technical capabilities have received authoritative recognition both nationally and internationally.
CNAS is the only laboratory accreditation agency in China and a mutual recognition agreement member of the International Laboratory Accreditation Cooperation (ILAC) and the Asia Pacific Accreditation Cooperation (APAC). Laboratories accredited by CNAS have their data and results mutually recognized in over 100 countries and regions worldwide, granting them international authority and credibility under the principle of "one test, globally recognized." Medicilon's Analytical Testing Center covers a total area of over 2,800 square meters, and its GMP system has passed multiple on-site inspections by the NMPA. Leveraging various technical service platforms, the center provides clients with integrated drug analysis solutions and technical services.
With extensive experience in the development, testing, and validation of methods for anions, cations, organic acids, and organic bases, dozens of salt-form drugs have successfully passed the clinical approval stage of the National Center for Drug Evaluation (CDE).
With extensive experience in the development and validation of residual solvent methods, over 100 solvents have been studied, supporting residual solvent quality research for more than 100 innovative and generic drugs.
With extensive experience in the development and validation of elemental impurity methods, studies have been conducted on various elements such as arsenic, cadmium, mercury, lead, cobalt, nickel, and vanadium. This work has supported elemental impurity quality research for more than 100 innovative and generic drugs.
With a wealth of preparation equipment and various advanced analytical techniques (such as NMR, LC-MS/MS, HRMS, and tandem mass spectrometry), we can provide clients with one-stop services that include targeted synthesis of drug impurities, impurity preparation, reference standard qualification, and impurity structure identification. Additionally, we can offer structure confirmation analysis reports that meet CTD requirements.
We can provide clients with method development, validation, and testing for microbial and bacterial endotoxin detection in raw materials and various types of formulations.
Equipped with the professional structural evaluation software Case Ultra, we support toxicological studies, including the Ames test (also known as the bacterial reverse mutation test). We have successfully completed genotoxic impurity research for over 50 products, developed more than 300 methods, and successfully assisted hundreds of pharmaceutical companies in addressing issues related to genotoxic impurities, elemental impurities, residual solvents, and biopharmaceutical process residues in their products.
We possess mature safety risk testing instruments and laboratory construction solutions for fine chemical reactions. As a professional developer of testing instruments and solutions in the chemical industry, we can provide services for reaction calorimetry experiments, thermal stability testing, and comprehensive safety risk assessment related to reaction safety research and evaluation.
We offer one-stop services for drug analysis R&D, stability testing, quality control, and CMC regulatory documentation, suitable for both China and global submissions.
Established in 2019, this platform is equipped with qualified and comprehensive testing instruments, a skilled analysis team with extensive experience, multi-faceted testing capabilities, and a robust platform management system. It is capable of undertaking physicochemical analysis and testing for projects developed and produced by Medicilon's Process Department.
We have a specialized and refined research service team equipped with over 100 instruments, including NMR, SFC, UPCC, ICP-MS, IC, LC-MS/MS, Prep-HPLC, DSC, and TGA. We have also introduced a categorized sample management system that implements automated management and clear pricing, primarily serving the fields of chemistry, pharmaceuticals, and chemical engineering.
This platform is dedicated to providing clients with comprehensive preclinical research services for active pharmaceutical ingredients and formulations, including pharmacokinetics and safety assessment studies, IND registration applications, as well as pharmaceutical research services for generic drugs. This includes reverse formulation analysis, formulation process research, quality control studies, stability studies, and in vitro bioequivalence evaluations. The research projects encompass various types of formulations, including solid, liquid, injectable, semi-solid, inhalation preparations, and liposomes.
This successful accreditation is the inevitable result of Medicilon's long-term commitment to enhancing the overall strength of its laboratory and serves as a strong testament to its continuous pursuit of excellence and empowerment of the global biopharmaceutical industry. In the future, Medicilon will continue to uphold a scientifically rigorous attitude, constantly improve its technical capabilities and management standards, expand its CNAS-recognized service offerings, and provide higher quality, efficient, and comprehensive analytical testing services. Together with global partners, Medicilon aims to promote the prosperity and development of the biopharmaceutical industry.
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