Your Strategic CDMO Partner — From Molecule to Market

Analytical Services

Comprehensive analytical development and validation supporting regulatory submissions, product release, and long-term lifecycle management.

Small Molecules

• Method Development and Validation
• ICH Stability and Release Testing
• Material Characterization
• Impurity Identification and Testing
• Extractables and Leachables (E&L)
• Nitrosamine Testing
• Elemental Impurities
• HPAPI and Sterile Product Support

Large Molecules

• ADC Testing
• Protein & Polypeptide Testing

Small Molecules →Biologics →

Product Development

Strategic formulation and CMC development designed to advance APIs into stable dosage forms ready for clinical development.

• Pre-Formulation Studies
• Formulation Development (QbD Driven Approach)
• Process Development
• Preclinical and Clinical Trial Material Manufacturing
• Clinical Packaging and Labeling
• HPAPI Formulation and Potent API handling

Product Development →

Drug Discovery & Process Development

Integrated discovery and process chemistry designed to deliver scalable, efficient routes from early research through API scale-up.

• Early-Stage Scientific Support
• mg–g Scale API and Intermediate Production
• kg-Scale API Manufacturing
• DMF Filing & Regulatory Support

Drug Discovery & Process Development →

Stability Storage & Testing

ICH-compliant stability storage and analytical testing supporting clinical development and global regulatory submissions.

• ICH Stability and Release Testing
• Stability Storage Conditions (ICH-Compliant)
• Stability programs for small molecules, peptides, biologics, and medical devices

Stability Storage & Testing →

CTM Manufacturing

GMP-compliant clinical trial material manufacturing supporting early-phase studies and regulatory submissions.

• Sterile Manufacturing Capabilities
• CTM Manufacturing for Non-sterile Products
• Preclinical → Phase I → Phase II

CTM Manufacturing →

Custom Synthesis

Flexible synthesis support for API intermediates, reference standards and impurities.

• API intermediates
• Reference standards
• Impurities

Start a Project →