What we do
GLP Bioanalysis
Agilux Laboratories' management and scientific staff have proven track records and collectively many decades of experience in building fully GLP compliant operations and delivering services supporting nonclinical through Phase III clinical studies, ultimately resulting in the successful approval of multiple products. Drawing upon the collective experiences of our staff across years and industry leading organizations, and in combination with luxury afforded our recent launch of these services, Agilux has implemented procedures, processes and a fresh approach to supporting GLP bioanalysis. Consistent with this approach, Agilux is currently implementing a comprehensive and integrated electronic laboratory notebook/laboratory information management system (ELN/LIMS) that will increase our speed of execution, improve data quality and regulatory compliance and ultimately enable the power to query, interpret and apply knowledge obtainable from the collection of data in a functional, integrated database.
Method Development
Consistent with and extending the approach employed in supporting our client’s discovery needs, Agilux Laboratories incorporates similar approaches to our Method Development efforts. Leveraging the power of LC/MS/MS in conjunction with incorporating a series of procedural and technical probes, Agilux gains increased efficiency in effectively troubleshooting and interpreting the results of method development experiments and most importantly, greater knowledge of the fidelity of experimental execution.
Method Validation
Agilux Laboratories is firm in its belief that investments in method development provide dividends in method validation and its subsequent application to the analysis of study samples. Our assays are validated in full compliance with the GLPs, FDA guidance documents and your company’s SOP as required.
Sample Analysis for GLP Studies
Agilux laboratories is capable of supporting a wide variety of GLP programs, including oftentimes difficult tissue based assays. The listing below provides a partial list of our experiences and offerings:
Study Types
Prodrugs
Ocular studies
Combination medical device studies (including stents)
Dermal
Endogenous compounds
Light sensitive compounds
All tissue types ( including brain, liver, lung, tumor, eye tissues, skin, artery)
Compliance
We conduct studies in accordance with guidelines set forth by the US FDA and Organization for Economic Cooperation and Development (OECD). We will validate any study in accordance with ICH guidelines.
Download the GLP Bioanalysis Datasheet
