We are committed to providing high-quality products to satisfy patient evolving needs, complying with applicable regulations, implementing continuous improvement.
We consistently adhere to the concept of "Quality by Design" (QbD) and foster a quality culture among all staff. Our quality system is constructed and maintained in alignment with up-to-date guidelines and standards from ICH, US FDA, NMPA, EMA, WHO, PIC/S, ISPE and PDA to ensure full compliance and efficient operations. We are dedicated to providing safe, effective and high-quality products to patients.
Since the establishment in 2006, Kindos has built and continuously improved its quality system based on international quality standards and current regulations, including those from ICH, US FDA, NMPA, EMA, WHO, PIC/S, ISPE and PDA. We consistently adhere to the concept of "Quality by Design" (QbD) and maintain a ''Quality-First'' culture that guides our team in upholding compliance as a fundamental principle. Kindos team ensures the sustained and highly efficient operation of an internationally high-standard quality management system, dedicated to providing safe, effective and high-quality injectable products to patients, enhancing confidence in life and health.
Since the first US FDA inspection in 2012, Kindos has become one of the first pharmaceutical enterprises in China to achieve FDA certification for sterile injectables. To date, we have consistently passed multiple on-site inspections by US FDA, NMPA and EU QP, as well as consecutive client audits from Fortune 500 pharmaceutical enterprises. Notably, FDA inspections in 2016, 2019 and 2024 resulted in zero deficiencies. Kindos commitment to controlling risks through a robust quality management program and continuous improvement, focusing on regulatory compliance and client orientation, has earned it a high level of recognition from the agencies and clients.
A validation system for sterile formulations and biological drug substances that complies with the requirements of regulatory agencies such as US FDA, NMPA, EMA, and follows the guidelines from ICH, WHO, PIC/S, ISPE and PDA, while being updated and continuously improved.