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CRO

Technical

API process development

We provide an one-stop service from preclinical study to commercialization, to support drug progression into clinical trials and market launch, including early-stage compound synthesis development, clinical-stage-III compounds or API process validation, commercial API production and regulatory strategies.

Powerful R&D Capability

With over-20-year experience in API development, Wisdom has established itself as a strategic partner to multiple top-10 global pharmaceutical companies. In recent years, Wisdom has achieved breakthroughs in proprietary technologies such as chiral synthesis and peptide synthesis. It has brought 5 Class-1 innovative drugs to market, obtained approval for over 10 first-to-market generics, and got more than 30 API registration numbers, while cumulatively developing over 500 compounds. The company has adopted a green and sustainable business model characterized by low energy consumption, low emissions, and high efficiency.Our R&D headquarter in Haimenu is equipped with over 200 fume hoods and boasts a robust team of more than 200 scientists, over 30% of whom hold master’s degrees.

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.

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Service

CRO

Technical

API process development

Powerful R&D Capability

Service

Service Scope

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