Chemistry, Manufacturing and Controls (CMC) Supportive Services

Establishment of regulatory documentation for drug identity, quality, purity, potency and stability.

(Scope: Small molecules, antibodies, exosomes, cell therapy products.)

Backed by advanced high-resolution mass spectrometry, Trifecta MedTek delivers precise analytical results and highly reliable methods aligned with regulatory guidelines. We ensure candidates’ physicochemical stability and manufacturing consistency, providing a solid foundation for regulatory review and market entry.

Core technology

• Establishing Drug Identity and Quality
• Monitoring Drug Concentration in vivo
• Facing Complex Emerging Drugs and the Future

Services Item

• CMC Consultation
• Method Development and Validation
• Stability Testing
• Biomedical Testing
• Critical Quality Attributes (CQA) analysis