GLP BioAnalytical Services

CPR serves the pharmaceutical and biotechnology industry by combining advanced analytical instrumentation with superior technical expertise. We develop, validate, and perform sample analysis in support of clinical, pre-clinical, and discovery studies in a stringent GLP environment. We provide rapid turnaround for Phase I and bioequivalence studies.

We have core competencies in small molecule and peptide analysis utilising state of the art LC/MS/MS technology. Our depth of experience translates into shorter turnaround times for method development and more rugged LC/MS/MS assays.

CPR has developed and validated more than 30 bioanalytical methods for NCE compounds from small molecules to peptides for first time in man studies. We also have a list of fully validated non proprietary methods which are available on request.

Our services include:

• GLP bioanalytical services
• Method development
• Method validation
• Method transfer
• Dose formulation analysis
• Clinical, pre-clinical and discovery sample analysis
• TK/PK analysis and reporting

Studies we support include:

• Pharmacokinetic
• Toxicokinetic
• ADME
• Bioavailability
• Bioequivalence
• Drug interaction
• Phase I to IV
• Post marketing

For more information, please contact us.