Phase II

Eurofins CDMO (Contract Development & Manufacturing Organization) will help you set the stage for the commercial process in Phase II of your drug development program.

Validated processes for 7 API products

Our development team works closely with clients to provide phase-appropriate solutions to balance their immediate and long-term API development needs.

Our Capabilities Include:

• Route or step rebuild
• Process optimization & demonstration
• Impurities assessment & synthesis
• Full structure characterization & elucidation
• Analytical method development & qualification
• Stress studies & ICH stability standards
• CMC gap analysis for commercialization
• Drug Substance process development with analytical support (Small Molecules / Biologics)
• Drug Product formulation and process development with analytical support (Small Molecules / Biologics)
• Sterile and Non Sterile Manufacturing with analytical support
• Clinical Packaging and Logistics