Service
Service Scope
Wisdom serves over 100 customers globally, with projects covering the full cycle from preclinical to commercialization stages. Since 2018, Wisdom has completed the market launch of more than 5 APIs annually, including Class 1 innovative ones and first-to-market generics. Strategic collaborations have been established with multiple local and multiple-national leading pharmaceutical companies. Depending on the stage of the projects, our experienced team will tailor appropriate process development strategies for customers.
Early-stage process development projects
Rapid-response mechanism is adopted to optimize processes on a fit-for-purpose basis and complete process route screening and crystallization process researching, helping clients achieve IND submission and clinical trial initiation at the earliest possible time.
Post-clinical and commercial projects
On the basis of successful commercialization experience, Wisdom can provide clients with process scale-up and optimization services, including process development, cleaning method development, critical process parameter identification, control strategies for developing materials/intermediates/APIs and scale-up and commercial production facilities to deliver full-industry-chain services from laboratory-scale to pilot-scale, process validation, and commercial production.
Comprehensive analytical support
The analytical team of Wisdom can address diverse analytical requirements across various stages from preclinical to commercialization, covering analytical method development and validation, stability studies, compound structure confirmation, impurity preparation and characterization, genotoxic impurity studies, elemental impurity studies, polymorph studies, standard reference substance preparation and characterization, microbial limit test method development and validation, cleaning method analytical validation, and other analytical modules.