QPS Delaware

QPS, LLC is a GLP/GCP-compliant CRO, specializing in discovery, preclinical, and clinical drug development research.
Located in Newark, Delaware, USA, it was established in 1995 and currently has 250 employees.

Small molecules bioanalysis:
LC-MS/MS.
Translational medicine (large molecule) (TLM):
PK, ADA, biomarkers, cell-based NAb assay, cell-based potency assay over ELISA/Bio-Plex/cell assay platforms, genetic analysis, qRT-PCR, as well as state-of-the-art LC-MS/MS methods for peptides and proteins.
Drug metabolism and pharmacokinetics (DMPK):
Discovery LC-MS/MS bioanalysis, oligonucleotides LC-MS/MS bioanalysis, protein binding, CYPs and transporters, PK/TK, metabolite identification, mass balance, and whole-body autoradiography, etc, with rodent vivarium.
Clinical research services:
Project management, regulatory affairs, medical monitoring, CRA, clinical consultancy, trial logistics, legal representation, pharmacovigilance, medical writing/PK/PD/biostatistics, and data management.

30,000 square feet of bioanalytical (small molecule) facilities (Newark, Delaware); 24,000 square feet of translational medicine facilities (Newark, Delaware); 16,500 square feet of DMPK facilities (Newark, Delaware); and 5,000 square feet of DTRL facilities (Fargo, North Dakota).
Bioanalytical, biochemical, radionuclide, and microbiological laboratories.
AB Sciex triple-quad mass spectrometer platform with Nexera UHPLC front-ends and Tomtec automated liquid handlers: bioanalytical (API 4000, API 5000, API 6500); TLM (API 6500, API 6500 Q-Trap); DMPK (API 4000, API 5500 Q-Trap, API 5600 High Resolution, API 6600); and DTRL (API 3000).
VersaMax microplate readers, SpectraMax multi-mode plate reader, Meso Scale Discovery S 600 ECL, Gyrolab xPlore, Quanterix SR-X.
Gamma and beta counters, radio flow detector, LC-DAD/UV equipment, and oxidizers.
LIMS (Laboratory Information Management System) for data management, analytical run acceptance, materials management, storage management, and equipment validations/management: WATSON, Debra.

At least 260 client audits completed.
Client audits increased 54% (due to new clients/growth), while the number of client observations have decreased 49%.
11 US FDA inspections completed with 36% free from citations.
6 CLIA inspections and certifications earned.
No agency escalation or warning letter ever received.
No employee has been debarred or in proceedings for debarment by the US FDA.

Animal Welfare Assurance from the Office of Laboratory Animal Welfare, National Institutes of Health, and the Department of Health and Human Services (Assurance Number: A4360-01).
Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC International / Number: 001067).
Certificate of Compliance, Clinical Laboratory Improvement Amendments, Centers for Medicare and Medicaid Services (CLIA Identification Number: 08D0995854).
Minority Business Enterprise Certification (NAICS Code: 541711), PA-NJ, DE Minority Supplier Development Council (Certificate Number: DE0463).

Extensive validated bioanalytical assay list (1,000+ assays developed and validated in blood, serum, plasma, tissue, saliva, sputum, and formulations — and growing) for which a lower limit of quantitation of 1 pg/mL is no longer an exception.
Over 5,000 bioanalysis studies conducted and more than 2 million samples analyzed.
20+ years of experience in the development, implementation, and validation of quantitative LC-MS assays for small molecules, peptides, proteins, and oligonucleotides, employing multiple bioanalytical platforms.
Over 15 years of development, implementation, validation of ligand-binding, hybridization, and enzymatic assays for the quantification of biopharmaceuticals and biomarkers in complex biological matrices.
Over 30 years of dermal and transdermal safety, BA, BE, and in vitro pharmacokinetics experience.