Manufacturing

生产

Our primary manufacturing facilities are located in the Fengxian Industrial Park in the greater Shanghai area. The facilities have been fully GMP operational since 2011. The highly experienced technical and plant operation teams, including project management and...
Manufacturing

CMC CTD注册支持

Registration starting material strategy Impurity management – fate and linkage Potential genotoxic impurity management API manufacturing and analytical information in formats appropriate for inclusion in regulatory filings (CTD Section 3.2.S.1 through 3.2.S.7)  Drug...
Manufacturing

ICH稳定性研究

Stability Chamber (IQ/OQ/PQ, annual calibration): temperature, humidity, light Stress testing, accelerated, intermediate, long-term, etc. Stability sample management Stability testing: chemical properties, physical properties   Stability Management Development of...
Manufacturing

制剂开发制剂开发

ChemPartner’s formulation group specializes in the development of novel solid and liquid dosage forms. Liquid dosage forms such as oral solutions, suspensions, and injectables have become the focus for pre-clinical safety evaluation in the industry. We are proud to...
Manufacturing

预前开发

Pre-Formulation Support: Salt selection screeningPolymorph screeningThermal propertiesSolubility profilingHygroscopicityMicroscopy and morphologyCrystallinity evaluationFlowabilityParticle size and distribution measurementBulk and tap densitiesLog P/Log D and pKa...
Manufacturing

分析研发

With extensive scientific knowledge and experience with the regulatory requirements of both the international and domestic markets, ChemPartner’s analytical development group provides strong support for drug substance and drug product development. The quality of our...
Manufacturing

工艺安全

Process safety and hazard assessment are a vital aspects of development. ChemPartner has an experienced and dedicated team responsible for process safety and hazard assessment evaluation. The team performs process hazard analyses and preliminary hazard and operability...
Manufacturing

流程研发服务

Our experienced teams at ChemPartner provide creative and innovative chemistry solutions for our clients’ chemical development projects. The quality of our chemical development services comes from innovative scientific approaches, effective communication,...