We effectively deliver high-quality clinical supplies with our strong suite of analytical services. This reliable analytical data keeps your program on schedule throughout every step of process development, formulation development, and the manufacturing of clinical trial materials.
Our Good Manufacturing Practice (GMP)/Good Laboratory Practice (GLP) analytical laboratories provide a broad range of method development services, phase-appropriate method validation, and routine quality-assessment testing.
As your product advances through preclinical and clinical phases and moves toward commercialization, you can also take advantage of seamless technology transfers to our FDA-registered, GMP laboratory testing facilities. Our central laboratory services ensure studies are appropriately transferred, validated and executed in a manner compliant with regulations and industry standards.
In addition to the on-site capabilities and capacity, the full range of expertise and analytical capabilities from our network of laboratories is readily available to support specialty needs that may arise. Our team of scientists and professionals work together throughout our network to help your program stay on schedule and move through the clinic.
Preformulation/Solid State Characterization
- Drug-Excipient Compatibility Studies
- Differential Scanning Calorimetry (DSC)
- Powder X-ray Diffraction (XRD)
- Polarized Light Microscopy (PLM)
- Scanning Electron Microscopy (SEM)
- Particle Size Analysis (LLS)
- Forced-Degradation Studies
- Solubility Determination (aqueous/solvents)
- Texture Analysis
- Bulk Powder Characterization
Development & Analysis
- Related Substances
- Chiral Purity
- Residual Solvents
- USP Apparatus I
- USP Apparatus II
- Intrinsic Dissolution (paddle over disk)
- UV/Vis Spectrophotometry
- FTIR Spectroscopy
- Compound Specific Cleaning Verification Methods (HPLC)
- Total Organic Carbon (TOC)
- Karl Fischer Titration
- Viscosity Measurement
- pH Measurement
- Color Spectrophotometry