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Laboratory Profile: Smithers Pharma Services, LLC

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

790 Main Street

Wareham, MA 02571-1037 US