Analytical Method Development / Validation / Transfer

• Active Pharmaceutical Ingredient (API)
• Drug Products (Formulations)
• Achiral Method Development
• Chiral Method Development
• HPLC, UPLC, GC, Dissolution, IR, Moisture, etc.
• Assay, Related Compounds, Degradants

ICH Stability Testing

• API
• Drug Products
• Over-Encapsulated Products
• 5C, 25C/60RH, 30C/65RH, 40C/75RH, 50C/75RH
• Fully Validated ECSC’s - Monitored 24/7
• Photo Stability

Release Testing

• Drug Substances
• Drug Products
• Certificate of Analysis Generation
• Battery of Standard Tests
• Assay, Dissolution, IR
• Appearance, Moisture, Hardness, etc.

GLP/GMP Routine Sample Testing

Instrumentation

• Separate GMP Network
• Waters’ Empower CDS System (Oracle Based, Server System)
• HPLCs: Waters, Thermo Finnigan, and Agilent
  - Detection Modes: UV, Conductivity, Refractive Index, PDA, Fluorescence, and Electrochemical
• GCs: Agilent and Thermo Finnigan
  - Headspace and Direct Inject
  - FID, ECD, and TC
• Nicolet Nexus 670 FTIR
• TA DSC Q100
• TA TGA Q50
• HACH 9703 Particle Counter
• Hanson Dissolution Systems
• Agilent 8453 UV
• Disintegration, Hardness, pH, Moisture, Osmolality, and more ...

Warehousing

• Drug Substances
• Drug Products
• Distribution

GMP Manufacturing

• Phase I and II Supplies
• Powder in Capsule
• Powder in Vial

Clinical Packaging

• Primary
  - Capsule in Bottles
  - Tablets in Bottles
• Secondary
  - Packaging
  - Labeling
  - Warehousing
  - Global Distribution

GLP Dose Prep
Controlled Substances (DEA I – V)
Potent API/Drug Capabilities (Glove Box)
Report Writing
CMC Writing and Generation
Consulting