One-stop process development from preclinical studies to commercialization

Quality, time, and cost play critical roles in new drug development. Whether a project is in the preclinical stage or approaching commercial manufacturing, we tailor a process development strategy to help advance the drug candidate into clinical trials and the market as efficiently as possible.

Strong R&D capabilities

With years of experience in innovative drug development, we serve as a strategic partner to leading pharmaceutical companies. Our process technologies support diverse custom development requirements. Continuous-flow reactions, biotransformation, and other proprietary technologies help reduce energy use and emissions while improving efficiency and supporting sustainable development.

Our operations are located in Degan Industrial Park, Chongqing, with convenient transportation. We operate four manufacturing sites and have more than 100 R&D professionals and more than 100 sales professionals.

Our experienced teams develop a stage-appropriate process strategy for each customer project.

Early-stage process development

A rapid-response approach is used to optimize the process to fit project needs. Salt and polymorph screening and crystallization-process studies can also be completed to support IND submissions and the start of clinical trials.

Late-stage clinical and commercial projects

For late-stage and commercial projects, we provide route scale-up and optimization, including parameter acceptable ranges (PAR), critical process parameter (CPP) identification, design-of-experiments services for starting-material, intermediate, and API control strategies, and complete process-validation support.

Comprehensive analytical support

Our analytical teams support requirements from preclinical development through commercialization, including analytical-method development and validation, stability studies, structural confirmation, impurity preparation and characterization, reference-standard preparation and characterization, physicochemical characterization, and cleaning validation.