Enhancing drug discovery and development
through quality analytical services

GLP Quantitation

The GLP-quantitation services RMI offers include bioanalytical support for clinical studies and toxicology services including method development and method validation.

Bioanalytical Support for Clinical Studies

Support of small, large, and/or multiple clinical studies. Sample receipt, sample tracking, and sample suppository services. Method development, validation, and sample analysis performed in full compliance with regulatory guidelines. Complete quality assurance auditing at each stage of study. Bioanalytical report for regulatory submission with compliance statements. Interim results reporting and expedited bioanalysis available.

  • Single or multiple analyte method development.
  • Complete method validation or method transfer
  • Compliance with FDA and white paper guidances
  • Quality control sample and stock solution stability confirmation
  • Incurred sample reproducibility
  • Established batch acceptance criteria
  • Whole blood stability for sample collection integrity

Toxicology (GLP) Services

  • Bioanalytical analysis for toxicokinetics of non-clincal laboratory studies
  • Method development, validation, and sample analysis performed in full compliance with regulatory guidelines
  • Sample storage and solution stability confirmation. Incurred sample reproducibility evaluation
  • Complete and thorough quality assurance audits throughout study
  • GLP compliant bioanalytical report and documentation
  • Sample storage stability, solution stability and incurred sample reproducibility

These services are provided through our sister company Keystone Bioanalytical Inc.