BIOQUAL, Inc. is a nonclinical contract research organization in Rockville, Maryland. It describes itself as providing "comprehensive in vivo and in vitro preclinical research services to both commercial and government clients,"[S1] and states that it was founded in 1981.[S2] The cited pages list infectious disease and oncology models, and the company reports capacity for more than 2,400 non-human primates.[S3][S4] This profile summarizes the services, facilities, stated compliance information, and company facts most relevant to US sponsors.
Nonclinical services relevant to US drug developers
Infectious disease models
The company lists infectious disease models and biosafety level 3 capabilities. It states that its "scientists combine in vivo models, in vitro assays, BSL-3 capabilities and custom model development to support vaccine, therapeutic and translational research programmes,"[S4] and lists pathogenesis studies, vaccine and therapeutic testing, dose-ranging studies, infusion dosing, PK and safety testing, and BSL-3 studies among the study types.[S4] The pathogen list on that page spans viral targets including SARS-CoV-2 and SARS-CoV-1, RSV, influenza, Zika, chikungunya, dengue, Mayaro, HIV and the SHIV and SIV models, mpox, vaccinia, cowpox, mousepox and herpes simplex virus; bacterial targets including Staphylococcus aureus and Clostridioides difficile, with Mycobacterium tuberculosis listed as coming soon; and malaria as a parasitic target.[S4] The species and strains used for a given model should be confirmed with the company at the design stage.
Oncology models
For oncology the company offers in vivo and in vitro models and states that its "scientists support programmes from early-stage model selection through efficacy, safety and immune-response studies"[S5] across small molecules, cell therapies, gene therapies, immunotherapies and vaccines.[S5] Listed study types include drug efficacy testing in vitro and in vivo, combination therapy studies, immune response and T-cell activation assays, toxicology and safety testing, and model selection support.[S5] A tumor model table on that page names specific cell line and mouse strain combinations; sponsors should confirm the current panel with the company.
Laboratory services and IND-enabling support
In-house laboratory services cover immunoassays and viral load testing. Named assays include ELISA, western blot, flow cytometry, hemagglutination and hemagglutination inhibition, neuraminidase inhibition, Luminex, plaque reduction neutralization and microneutralization, ELISpot, the MTT cytotoxicity assay, plaque assay, TCID50 and RT-PCR pathogen detection.[S6] The company describes plaque reduction neutralization and microneutralization assays as quantifying "the ability of antibodies to neutralize viral infection in cell-based systems, supporting vaccine and therapeutic development programmes."[S6] On the regulatory side it states that its "IND-enabling services provide comprehensive support, including toxicology studies, pharmacokinetic profiling, GLP services, and regulatory documentation."[S7] An IND is not "approved" by FDA: under 21 CFR 312.40 it goes into effect 30 days after FDA receives it unless FDA imposes a clinical hold.[R1] A CRO may conduct and report nonclinical studies that a sponsor includes in an IND, but it cannot guarantee that FDA will allow the clinical investigation to proceed. Imaging and custom animal model development are also listed, with the company stating that it collaborates with clients "to create models that accurately mimic disease conditions and therapeutic responses."[S7]
Facilities and animal capacity
The company states that it has "five locations throughout Rockville, MD"[S3] and publishes housing capacity rather than square footage: "capacity for over 2,400 NHPs," "housing for more than 8,000 mice" and "space for over 800 ferrets."[S3] Only the headquarters address is published; the addresses of the other four Rockville facilities were not found on the pages reviewed. The company names infectious disease, oncology and immunology as its core research areas.[S3]
Quality, compliance, and animal welfare (as stated by the company)
GLP. The company lists "GLP services" as part of its IND-enabling support.[S7] The company's website does not name a specific GLP regulation (FDA 21 CFR Part 58, EPA 40 CFR Part 160/792, or OECD GLP) for its facilities.[S7] GLP compliance is determined study by study under the applicable regulation, so sponsors should confirm in the protocol which regulation their study will follow and that the final report will carry the study director's compliance statement and the quality assurance unit's statement.[R2] No GCLP or CLIA statement was found on the pages reviewed.
Accreditation, registration, and animal welfare. The mission and values page lists "accreditation with the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC),"[S2] status as a "registered U.S. Department of Agriculture (USDA) Class R Research Facility,"[S2] an "Office of Laboratory Animal Welfare (OLAW) Assurance,"[S2] and "having a duly constituted Institutional Animal Care and Use Committee (IACUC)."[S2] It also states that it is "incorporating the 3R's of animal research (Replacement, Reduction, and Refinement) to constantly improve our program"[S2] and provides an anonymous channel for animal welfare concerns.[S2] The cited page does not give accreditation dates, registration numbers, or an FDA inspection record; each status should be verified in the relevant official registry before publication.[S2] AAALAC International accreditation is a voluntary evaluation of an institution's animal care and use program, re-evaluated every three years,[R3] and USDA registration and an OLAW Animal Welfare Assurance relate to the Animal Welfare Act and the PHS Policy respectively;[R4][R5] none of these establishes GLP compliance, which applies to individual studies.[R2] FDA does not approve or certify laboratories; registration with FDA does not denote approval.[R6] This profile does not evaluate the company's animal care program; the statements above are the company's own.
The company states that it is "a public company traded on the OTC Markets Group ? Symbol BIOQ", and publishes audited and unaudited financial statements as PDFs on its own website[S8]
FDA ? "Is It Really FDA Approved?" (FDA does not approve health care providers, including laboratories; registration does not denote approval); FDA Compliance Program 7348.808 (GLP inspections of nonclinical laboratories). https://www.fda.gov/consumers/consumer-updates/it-really-fda-approved (accessed 2026-09-03)
3 Recommended Contract Research Organizations
for Non-Clinical Studies
— by Target goal and Expertise
In non-clinical development, the choice of contract research organization shapes the quality of the data and the time it takes to reach the next decision. Below, three CROs are introduced by the type of study they support: pharmacology (efficacy) studies, safety studies, and pharmacokinetic (PK/PD) studies. Each summary describes the services the company offers so that you can match a provider to your target and development objective.
Pharmacology (Efficacy) StudiesDisease-Relevant Models for Translational Drug Evaluation
Reference: SMC Laboratories, Inc. official website (https://www.smccro-lab.com/)
SMC Laboratories, Inc.
SMC Laboratories is a specialized non-clinical CRO focused on in vivo pharmacology and efficacy studies using disease-relevant animal models, particularly in fibrosis, inflammation, metabolic diseases, and oncology.
Areas of Expertise
Disease-Relevant Model Portfolio
SMC Laboratories offers models covering the liver, lung, kidney, intestine, and oncology. Its portfolio includes the proprietary STAM™ model for MASH, fibrosis, and hepatocellular carcinoma.
Study Design Based on Target Biology
Study plans are developed around the target biology, mechanism of action, disease stage, and development objective. Pharmacological endpoints can be combined with histopathology, biomarkers, and disease-specific readouts.
Support from Target Validation to Proof of Concept
With experience from more than 1,000 studies for clients in 30 countries, SMC Laboratories supports programs from target validation and candidate selection through in vivo proof-of-concept studies.
Safety StudiesComprehensive Safety Assessment for Preclinical Development
Reference: Charles River Laboratories official website (https://www.criver.com/)
Charles River Laboratories
Charles River provides non-clinical toxicology and safety assessment services for programs ranging from exploratory safety studies to IND-enabling development.
Areas of Expertise
General Toxicology Across Study Designs
Services include single- and repeat-dose toxicology, dose-range finding, and general toxicology studies across multiple species and administration routes.
Non-GLP and GLP Study Support
Charles River supports both non-GLP and GLP studies, allowing sponsors to progress from early safety characterization to studies intended for regulatory submissions.
Integrated IND-Enabling Safety Assessment
Toxicology studies can be integrated with toxicokinetics, clinical pathology, histopathology, and safety pharmacology to support interpretation and IND-enabling safety packages.
Pharmacokinetic (PK/PD) StudiesConnecting Drug Exposure with Pharmacological Response
Reference: Inotiv official website (https://www.inotiv.com/)
Inotiv
Inotiv provides integrated PK/PD, DMPK, and bioanalytical services to characterize drug exposure and its relationship with pharmacological response.
Areas of Expertise
Pharmacokinetic Characterization
PK studies characterize exposure, half-life, clearance, and other pharmacokinetic parameters needed to understand how a candidate behaves in the selected model.
Exposure–Response Evaluation
Pharmacokinetic data can be combined with pharmacodynamic endpoints and bioanalysis to evaluate the relationship between drug exposure and pharmacological response.
Integrated DMPK and Development Support
Integrated DMPK, pharmacology, and safety information supports candidate comparison, dose selection, dosing-frequency optimization, and decisions about subsequent preclinical development.
Japanese
