For our clients who work in a regulated environment, we offer the development and validation of analytical methods. Our team of experts can work with your team to create custom methods for the characterization of active pharmaceutical ingredients (APIs), medical devices, implants, and devices from the aeronautical and aerospace industries. In most cases, these methods will require validation to be compliant with applicable Quality System Regulations (QSRs), relevant ISO standards, and Good Laboratory Practices (GLP). Our team will ensure that our methods of analysis are compliant with any and all standards that apply to your drug or device and can execute a comprehensive validation based on these standards and internationally accepted validation guidance documents such as the ICH Harmonized Tripartite Guideline, Validation of Analytical Procedures.
In a typical validation, we demonstrate that the accuracy, precision, intermediate precision, linearity, range, specificity, robustness, detection limits, and quantitation limits meet or exceed that which is required for a successful submission to the appropriate agency. Our GLP-compliant reports often include several hundred pages of raw data, including calibrations, calibration verifications, certificates of analysis, and handwritten notes. Our GLP reports are written and reviewed by PhD-level scientists.