JDB电子·「中国」官方网站

CMC solution

• Pre-clinical
• IND
• Trial Ⅰ
• Trial Ⅱ
• Trial Ⅲ
• NDA
• Commercial

• 01process development
• 02API process optimization and validation
• 03API manufacturing
• 04synthetic service for IND
• 05MOA development and validation
• 06change control
• 07produce sample for toxicology study
• 08stability study
• 09RA support
• 10regulation consulting

Analytical service

• MOA development and validation
• Stability study
• API working standard
• releasing test
• cleaning validation
• characterization
• microbiological test
• Endotoxin test
• Polymorph test

Equipment

• HPLC
• GC+HS
• UPLC
• Preparative HPLC
• GCMS LCMS
• NMR
• UV FTIR
• DSC/TGA
• DSC/TGA
• XRD
• ICPMS

Our Advantage

• Integrated experienced team: process, purification, analytical, manufacturing, QA/QC and RA
• Well-equipped facilities
• Strong support from GMP and EHS compliance, pass FDA GMP inspection
• IP protection
• Project management system
• Faster response and Shorter lead time