Since 1999 KAR Bioanalytical, Inc. has offered method transfer, development, validation and analysis of preclinical and clinical biological samples in a GLP-compliant setting.

GLP Compliance:

At KAR Bioanalytical, regulatory compliance is an integral part of our daily operations. Our quality assurance unit has more than twenty years experience in the pharmaceutical industry. The FDA has inspected our facility twice in the last five years and KAR Bioanalytical has received no FDA form 483 inspectional observations. We are DEA licensed for controlled substance handling.

Bioanalytical Support:

Method Development, Validation, and Sample Analysis:
Over 150 bioanalytical methods have been validated at KARBio in 32 biological matrices from over a dozen species. We also transfer or modify existing methods. In the past two years KARBio analyzed human samples in support of 11 clinical trials and 4 drug candidates.

R & D Discovery Support:

KARBio provides low cost, rapid turnaround exploratory studies utilizing in vitro biochemical techniques and LC/MS/MS to guide project decisions on a weekly basis including metabolic stability, cytochrome P450 reaction phenotyping, rapid metabolite identification, and pro-drug conversion characterization.

Formulation Support for API:

Formulation methods have been validated at KARBio since 1999. Formulations including solutions, suspensions, gels, oils, creams, and animal feeds. We also provide rapid turnaround R & D support for manufacturing processes, including low-level concentration and content uniformity determinations.

Analysis of Pharmaceuticals in the Environment:

KARBio conducts analysis of local environmental samples using EPA method 1694.

Analytes, Including:

Anesthetics, Antibiotics, Essential Oils, Narcotics, Proteins/Peptides, Steroids, Vitamins, and Trace Metals.

KAR offers personalized support with an emphasis on quality, accuracy and speed. Our mission is to provide the best possible quality and service anywhere at competitive prices.