Our expert scientists will develop quality methods and analyze your study specimens according to the applicable regulations, help you anticipate scientific or regulatory challenges, offer strategic solutions to enable you to make critical strategic decisions, and report your results in an appropriate format.   We support many government (EPA, NIH, NCATS) and chemical (pharmaceuticals and agricultural chemicals) industries, see more details at the links below.   We have an excellent inspection record with clients and regulatory (FDA-CDER and EPA) auditors.
Our scientists have developed, validated and run multi-analyte methods containing up to 80 analytes (plus internal standards).   Specimen management services are also provided, including preparation of clinical specimen collection kits.   Dose solution analysis services are available upon request.
For more than a decade, we’ve developed fit-for-purpose analytical methods that meet (or exceed) our clients needs, including specificity and detection limits.   While quantification by HPLC-MS/MS is our specialty, we also have other capibilities, including UV and flow cytometry.
Bring your own method or have us develop one for you, and we’ll validate it to your industry’s applicable bioanalytical standards.   Since 2008, we’ve validated more than 100 analytical methods.
We’ll analyze your specimens for exogenous (e.g., administered drugs) or endogenous (e.g., steroid hormones, biomarkers) compounds in our state-of-the-art laboratory with the finest instrumentation.   Specimen options include dried capillary blood collection or DBS (e.g., using our patented amasse device) in addition to traditional venous blood/serum/plasma, urine, saliva, a multitude of tissues and other media like H295R Human Adrenocortical Carcinoma Cells.
We routinely perform bioanalytical method validations and bioanalysis in support of (i) non-clinical safety and clinical studies in accordance with FDA's GLP and Electronic Records and Electronic Signatures regulations, and Bioanalytical Method Validation Guidance for Industry, and (ii) environmental studies in accordance with EPA's GLP and Quality Management Plan (QMP) regulations.
We have more directed FDA inspections than the average CRO (one or more per year), because greater than 90% of clinical trial data we generate are submitted to FDA.