Global CMC Filing

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API & Intermediates CDMO Service

Process Development Service

Synthesis Route Design

Development & Optimization

QbD Study

Process Validation

Manufacturing Service

Process Development Service
Drug Product CDMO Service

Pre-clinical Drug Product R&D Service

Salt and Polymorph Screening

NCE Characterization

Pre Clinical Formulation Development

Clinical Drug Product R&D Services

Clinical and Commercial Drug Product Manufacturing Services

Global Regulatory Submission Services
Analytical Service

API Analysis Service

Pre-formulation Analysis Service

Drug Product Analysis Service

Stability Study

Data Integrity
Support

Global CMC Filing

Project Management

Product Lifecycle Management

For more information about

"Global CMC Filing",

please contact our team.

Global CMC Filing

We have an experienced, dedicated global regulatory affairs service team that provides CMC services for global customers in the drug's whole lifecycle, including Investigational New Drug Application (IND/CTA), New Drug Application (NDA/MAA), and Abbreviated New Drug Application (ANDA), post-approval regulatory services such as variation, annual report and re-registration etc.

Services Scope

CMC R&D activities, providing synchronous assessment, plan and feasibility consultation, providing regulatory compliance guidance and support

CMC filing preparation, compilation, and technical review ensure the quality of documents meet the submission requirements

Drug applications (DMF, ASMF, CEP, MF, APIMF, API registration filing, etc.) in the US, Europe, Japan, WHO, China, and other countries

Chinese and/or English translation services for filing documents

Good communication with authorities and timely feedback after submission