We have extensive experience supporting the following types of engagements:
Bioanalytical Method Development
Develop bioanalytical methods for pharmaceutical active ingredients, metabolites, and adjuvants from matrices including plants, animals, and humans. We support Phase I – III clinical studies, as well as post market surveillance.
Impurities Identifications
Develop analytical methods, identify and characterize or certify impurities in technical grade active ingredient, formulations, and biological matrices.
Method Validations
Validate analytical and bioanalytical methods, from straightforward method transfer demonstrations to comprehensive evaluations of accuracy, precision, repeatability, ruggedness, freeze-thaw, and stability.
ADME, PK/PD, Metabolism and Toxicology Support
Provide bioanalytical support for ADME, PK/PD, metabolism and toxicology investigations.
Bulk Drug Characterizations and QC Support
Support raw materials qualification, in-process batch analysis, finished product testing, and process troubleshooting, including turn-key support from method development or optimization through issuing certificates of analysis.
Occupational Exposure and Stewardship
Analytical chemistry support for occupational exposure and facilities decontamination. Method development and residue analytical support for matrices including biofluids, detergent wash water, dosimeter pads, and inhalation monitoring capsules.
Reporting and Quality Assurance
Our in-house QA department assures the integrity of all the data we generate and of all the reports we publish. For analytical studies, we often write protocols on behalf of sponsors, provide study direction for laboratory projects, and write progress reports and final reports. We provide reports in a wide range of paper formats as well as electronic submission formats including MS Word (.DOC) and Adobe Acrobat (.PDF).