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