Caremo Earns Another Authoritative Endorsement! Proficiency Testing Certificate Demonstrates Solid Bioanalytical Strength!

Recently, the bioanalytical laboratory of Caremo successfully passed the "2025 Proficiency Testing Program for Determining Ibuprofen Concentration in Rat Plasma by High Performance Liquid Chromatography-Mass Spectrometry (HPLC-MS)" organized by the National Institutes for Food and Drug Control (NIFDC). This achievement not only signifies that Caremo's analytical capabilities in this technical field have reached a nationally recognized level but also serves as strong proof of the overall quality management system and technical strength of the company's bioanalytical laboratory.

Proficiency Testing: The National "Benchmark for Quality"

Proficiency Testing is an authoritative assessment method that uses inter-laboratory comparisons to determine a laboratory's testing capabilities and is an important means of evaluating a laboratory's technical competence and the effectiveness of its quality management. As the core national institution for drug quality control and standardization research in China, proficiency testing programs organized by NIFDC represent the highest standard of technical evaluation within the domestic industry.

The test results submitted by Caremo's bioanalytical laboratory in this proficiency testing met NIFDC's stringent evaluation criteria in key indicators such as accuracy and precision, successfully passing the assessment. This outcome reflects not only the laboratory's profound expertise in method development and validation but also fully demonstrates its mature operations and excellent performance.

Ongoing Commitment: Providing Trustworthy R&D Support for Clients

Since its establishment, Caremo's bioanalytical laboratory has systematically built a management system covering quality management, technical operations, and support services. The laboratory obtained the Laboratory Accreditation Certificate (Registration No.: CNAS L23125) from the China National Accreditation Service for Conformity Assessment (CNAS) in April 2025.

Currently, the test data issued by Caremo's bioanalytical laboratory possesses authority, independence, and impartiality, and can be recognized in numerous countries and regions that have signed mutual recognition agreements. This provides solid data compliance assurance for partners, especially companies pursuing dual submissions in domestic and international markets.

CNAS accreditation is currently the most authoritative evaluation standard for laboratory quality management systems in China. Its accreditation criteria are fully aligned with the international standard ISO/IEC 17025, signifying that the laboratory's quality system and management level have reached nationally and internationally recognized standards.

Continuous Innovation: Providing Reliable Support for Drug Development

Caremo always regards data quality as its lifeline and is committed to building an integrated, internationally aligned, standardized, and efficient bioanalytical service platform. The laboratory is equipped with key instruments such as LC-MS/MS systems, high-precision balances, ultra-low temperature freezers, and data backup systems. It has also established a full-process standardized operational system covering method development, method validation, sample analysis, and data reporting.

In 2025, we completed method development and validation for nearly 30 compounds and undertook bio-sample testing for over 10 bioequivalence (BE) projects, all delivered successfully. In December of the same year, the laboratory underwent on-site inspections by the National Medical Products Administration for 2 compounds, continuously improving the system's construction.

In the future, Caremo will continue to deepen technical capacity building, expand the scope of analytical services, and provide more professional, reliable, and compliant bioanalytical solutions for pharmaceutical companies and R&D institutions both domestically and internationally.