A Leading global pharmaceutical Contract Research Organization

Analytical and Bioanalytical support

Pharmaceutical solutions from The Smithers Group - providing key services in drug development before and after formulation

Synomics Pharma, a member company of The Smithers Group, is co-located at the Wareham, Massachusetts facility.  Synomics offers a wide range of analytical and bioanalytical testing services, which can be contracted to support characterization needed throughout development. Working with the flexibility of an R&D environment or according to the rigor of GLP or cGMP guidelines, a number of analytical chemistry services are available to characterize APIs.

Employing state-of-the-art instrumentation in HPLC, GC, GC/MS and LC/MS/MS, Synomics can develop analytical chemistry methods from first principles to validate and can verify or improve existing methods for the analysis of a wide range of active compounds. Customized analytical chemistry testing and structure elucidation are also offered. ICH-compliant stability studies are performed at our Massachusetts facility in fully-validated climatic chambers for CMC packagings or IMPD filings.

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For more information, download our Pharmaceutical Solutions technical brief.

 

All services can be provided to meet either GLP or cGMP guidelines (or non-GLP as requested) 

Analytical Chemistry Services

Method development
Method validation

Method verifications/transfer
Sample analysis
Lot and batch release testing
Structure elucidation
Detection and identification of impurities
Residual solvent analysis
Dissolution testing
Product composition
Content uniformity/impurities
Customized LC/MS/MS method development 
Raw material testing
Placebo and excipient testing
Physical-chemical properties

Customized analytical testing