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GEL Analytics has extensive experience providing GLP compliant data for drug discovery and clinical studies. We have developed our Standard Operating Procedures to ensure strict adherence to FDA GLP guidelines using the FDA’s Guidance for Industry Bioanalytical Method Validation from May 2001. These guidelines can be found at http://www.fda.gov/cder/guidance/4252fnl.pdf.
We offer the following GLP Bioanalytical services:
- Method Development – We work with our clients to identify specific requirements for the method to be developed, the timeline for development and any unique considerations that are important to the project. The method is developed to meet the bioanalytical validation guidelines and any unique client requirements.
- Method Validation – Prior to initiating a method validation, we prepare a protocol that is approved by the client prior to the commencement of the validation study. Our staff confers with the client to determine the extent of validation required, which varies from project to project. The elements of the method to be validated are those outlined in the FDA bioanalytical method validation guidelines. We provide a method validation report that summarizes all of the validated elements and maintains the supporting raw data in project folders in the GEL Analytics archives, where the data is stored in compliance with FDA requirements and is available on request.
- Non-clinical Sample Analysis – We provide analysis for non-clinical projects. We have experience with plasmas, tissues and feces in rat, dog and monkey matrices. Samples are analyzed in specific batches with clearly defined acceptance criteria to ensure that each result will meet regulatory requirements.
- Clinical Sample Analysis – We provide analysis for clinical trials in a variety of matrices including plasma, urine and feces. We have demonstrated sufficient throughput to meet the timelines of any clinical trial and will provide the data in any requested format.
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