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Small Molecule Drug Development:
GMP & GLP Testing

GMP and GLP Services

Drug Substance and Drug Product

Preclinical and Clinical Samples

 


 

GMP and GLP Services

Wolfe Laboratories’ integrated translational drug development services enable a seamless transition from analytical and drug product development to preclinical and clinical studies in a manner compliant with regulations and industry standards.

 

Drug Substance and Drug Product

Wolfe Laboratories provides stage-appropriate development, qualification and validation of analytical methods, characterization and release testing of drug substance and drug product, and stability testing in a GMP- and GLP-compliant environment. Wolfe Laboratories supports GMP manufacturing by performing analytical and process technology transfer to one of its manufacturing collaborators or to a manufacturer selected by the client and by providing project management, in-process, release and stability testing as required.

 

Preclinical and Clinical Samples

Wolfe Laboratories provides GLP bioanalytical services for testing of biological samples from preclinical and clinical studies, including stage-appropriate LC-MS/MS method development and validation, testing of biological samples, incurred sample reanalysis (ISR) and long-term storage stability assessment.