Jiangsu Dongke Kangde Pharmaceutical Co., Ltd. Obtains ISO9001 Certification, Ushering in a New Chapter of Quality Management!

Recently, Jiangsu Dongke Kangde Pharmaceutical Co., Ltd. (hereinafter referred to as "Dongke Kangde"), a wholly-owned subsidiary of Caremo, officially obtained ISO9001 Quality Management System certification, with its scope covering research on chemical generic drug.

This achievement marks a significant step forward in Dongke Kangde's standardized R&D processes and systematic quality management system development, further enhancing its professionalism and reliability in the field of generic drug research.

ISO9001, an internationally recognized quality management standard, emphasizes customer-centric approaches and continuous improvement through systematic and standardized process management. For pharmaceutical R&D enterprises, this certification not only validates existing management systems but also demonstrates rigorous scientific practices throughout the entire drug development process.

During the certification audit, expert reviewers highly commended Dongke Kangde's professional R&D team and well-established management systems. The company consistently adheres to its philosophy of "Science as the Foundation, Quality First," integrating quality control throughout the drug development lifecycle while maintaining scientific management, technology-driven approaches, and compliance-oriented operations.

Established in June 2021 as a wholly-owned subsidiary of Nanjing Caremo Biomedical Co., Ltd., Dongke Kangde provides comprehensive one-stop services for Marketing Authorization Holder (MAH) projects across their entire lifecycle. These services encompass CMC development, supplier management/audits, CMO selection/audits, technology transfer, clinical audits, entrusted production supervision, sales/distribution management, traceability management, and pharmacovigilance management.

From project initiation to commercialization, Dongke Kangde offers MAH clients integrated solutions to meet diverse needs. The company successfully obtained its Category B Drug production license in September 2022.