Demonstrating that a method is fit for purpose

The development of sound bioanalytical method(s) is of paramount importance during the process of drug discovery and development culminating in a marketing approval. The development and validation of these methodologies play an important role in the evaluation of the safety and toxicological effects of these early stage drug developments. This service offers the development and validation of regulatory compliant bioanalytical methods that can be routinely used to support either discovery or preclinical studies.

With over 20 years' experience in the development of technically challenging and sensitive ELISA assays, we offer:

• Custom Assay Development
• Single or multi analyte methods
• Validation parameters that are routinely tested:
  • accuracy
  • precision
  • selectivity
  • sensitivity
  • reproducibility
  • stability
• Incurred Sample Reanalysis

We provide analytical chemistry and quality control support for Method Development and Validation in accordance with the FDA Guidance for Industry on Bioanalytical Method Validation.

For further information on our Global service offering please email pharmaservices@gen-probe.com