R&D Services

FTE/CUSTOM SYNTHESIS SERVICE

• ● Rapid delivery of new compounds, positive control molecules, impurities, blocks, intermediates, APls in milligrams to hundreds of grams
• ● Quick Route Design for New Compounds and Blocks
• ● Multi step synthesis of complex compounds
• ● Customized synthesis project, quotation within 2 working days
• ● Core team with over 15 years of synthetic experience
• ● There are pharmaceutical synthesis laboratories in both Wuhan and Suzhou

PROCESS CHEMISTRY AND PROCESS RESEARCH SERVICES

• ● Process route design/screening/optimization/amplification
• ● Continuous cost optimization and new process development
• ● Process safety test and stability study
• ● Process transfer
• ● Coordination of production and supervision of process validation batches
• ● Development, validation, and validation of analytical methods
• ● ICH stability study
• ● CMC registration data support

PRODUCTION SERVICES FOR RAW MATERIALS AND INTERMEDIATES

• ● Development of APl and intermediate process routes
• ● Solve the industrialization problem of high difficulty starting materials
• ● Explain the logic of starting material quality control

Establish standards for central control and intermediates; Establish quality standards for raw materials Preparation and standardization of reference materials for raw materials

• ● Production of toxicological batches, production of registered batches, and production of clinical research batches

The generation and removal of impurities in the process flow; Write registration materials

QUALITY RESEARCH AND REGISTRATION APPLICATION SERVICES

Development, Validation, and Validation of Quality Research Methods Writing of clinical registration and application materials for raw materials

• ● Application Research and Application Data Writing for Raw Material Drug Production

Consultation and communication with regulatory departments