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Smithers Pharma Services, LLC

790 Main Street

Wareham, MA 02571-1037 US


Smithers Pharma Services, LLC Services:

Pre-clinical and clinical drug formulation development services

GLP and cGMP Analytical Chemistry Services - Custom research, formulation and stability support
Method development
Method validation
Method transfer/verification
Detection and identification of impurities/impurity profiling
Extractable/leachables
Assay/content uniformity
Stability indicating assay method development
Lot and batch release testing
Dissolution testing
Analysis of chiral compounds
Raw material testing
Placebo and excipient testing
Physical-chemical properties
Customized analytical testing
Project management and consulting

Preclinical and Clinical Bioanalytical Services
GLP and non-GLP services
Customized LC/MS/MS method development for biological fluids, tissues and explants devices, with strategies to ensure method robustness
Stage-specific LC/MS/MS validation in accordance with FDA and EMA guidelines and current industry best practices
Continually expanding list of validated methods for non-proprietary compounds
Sample analysis for clinical and non-clinical studies
Biomarker services
In vitro and in vivo metabolism services, including metabolite identification
Consulting, training, and troubleshooting services

Stability Storage & Testing Support
Long-term stability
Accelerated stability
Intermediate stability
Semi-permeable stability containers
Refrigerated stability
Freeze-thaw cycling
Photostability - Option 1