Whether your focus is on small molecules, proteins, vaccines, or oligonucleotides, you can trust QPS to deliver bioanalytical solutions and provide you with a full range of Contract Research Organization (CRO) services. QPS has three bioanalysis technology platforms: LC/MS/MS for small molecules and polypeptides, ELISA for proteins and vaccines, and hybridization-ELISA for oligonucleotide-based drugs.

QPS bioanalytical groups support the whole spectrum from early discovery to IND-enabling ADME to clinical studies. The ratio of clinical to preclinical studies fluctuates, however, it averages out at approximately 60/40 over the years.

GLP bioanalysis in QPS are conducted in compliance with the Food and Drug Administration (FDA) Good Laboratory Practice Regulations (GLP) as set forth in Title 21 of the U.S. Code of Federal Regulations Part 58; the Organisation for Economic Co-operation and Development (OECD) Principles of Good Laboratory Practice [C (97) 186/Final]; the Japanese Ministry of Health, Labor, and Welfare (MHLW) No. 21, March 26, 1997; and the FDA Guidance for Industry for Bioanalytical Method Validation, May 2001. A QA signature page will be included in the report verifying the quality of the data.

In addition, QPS can provide full PK/TK analysis for a preclinical or clinical study using validated software programs such as WinNonLin and Watson. We also provide fully integrated BA/PK reports appending the bioanalytical results to the PK/TK interpretation.

Thorough research backed by detailed data delivers quality results for our clients and partners. In addition, we provide you with direct access to our technical staff, regularly scheduled updates in a format that works for you, and prompt, courteous answers to your inquiries.

For more details on specific bioanalytical technology platform please visit our Small Molecule Drugs FAQs, Protein Drugs & Vaccines ELISA FAQs, and Oligonucleotides Drugs FAQs pages.

At QPS, we continually strive to be the best.