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Smithers Pharma Services, LLC

790 Main Street

Wareham, MA 02571-1037 US

Smithers Pharma Services comprises top experts in the pharmaceutical field, and is a member of The Smithers Group, an independent global leader in delivering trusted solutions by integrating science, technology, and business expertise. Our companies are innovative in adding value throughout the life cycle of our clients' products utilizing testing, consulting, information and compliance services. Backed by a strong reputation and years of experience, every Smithers Group company brings you high quality services and expert guidance that you can trust.

Technical Information:

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
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

DISCLAIMER: This Laboratory Profile was provided by the company above.