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 drug discovery, the quality and efficiency of non-clinical studies have a direct impact on clinical success rates, development costs, and overall length of time required in R&D.
In recent years, there has been more demand for clinically relevant data, globally accepted reliability, and accurate early-stage screening.
Thus, it is more important than ever to select the right CRO (Contract Research Organization) for strategic approach.
In this article, we highlight three CROs with proven technical capabilities, expertise, and long standing track records. These are our TOP 3 choices based on their capabilities and the specific target goals of the researchers for their non-clinical studies.
Pharmacology (Efficacy) Studies Replicate unknown pathological models and Discovery to clinically oriented drug evaluation
SMC Laboratories, Inc.
Reference: SMC Laboratories, Inc. official website (https://www.smccro-lab.com/jp/)
SMC Laboratories, Inc. has established a disease models using patented mouse technologies.
The company has established proprietary pathological models—particularly in liver disease and fibrosis—and continues to expand their approach across a wide range of models in cancer, inflammation, and metabolic diseases.
From exploratory research to clinically oriented efficacy evaluation, SMC offers customized study designs, dosing strategies, and evaluation analysis tailored to each project.
Their collaborative approach allows researchers to discuss and refine study plans together with SMC’s expert scientists.
With flexible small-scale study options and strong technical support, SMC Laboratories, Inc. is an ideal partner for start-ups, biotech ventures, and academic institutions alike.
Safety Studies Comprehensive Safety Evaluation for FIH Applications
Labcorp Holdings Inc. (Labcorp Drug Development)
Reference: Labcorp Holdings Inc. official website (https://jp.labcorp.com/)
Labcorp Holdings Inc. provides a fully integrated GLP testing system aligned with international regulatory standards, including FDA, EMA, and PMDA requirements.
All studies are conducted under ICH-compliant quality assurance, making it ready for data submission.
The company has extensive expertise in long-term toxicity studies such as Segment I–III reproductive and carcinogenicity studies, as well as 2-year chronic toxicity assessments.
Labcorp Holdings Inc.’s comprehensive approach enables sponsors to efficiently outsource the entire preclinical package from toxicology, toxicokinetic (TK), and safety pharmacology study design to execution. This accelerates a path to First-in-Human (FIH) trials.
For most of the global drug developers, this all-in-one service structure minimizes cost, risk, and expedite the time before advancing to clinical phase.
Pharmacokinetic (PK/PD) Studies High-Precision Bioanalysis for Clinically Predictive PK/PD Evaluation
PhoenixBio Co., Ltd.
Source: PhoenixBio Co., Ltd. Official Website (https://phoenixbio.co.jp/)
PhoenixBio Co., Ltd. offers pharmacokinetic and hepatic metabolism studies using their proprietary PXB-mouse®, a humanized-liver chimeric mouse model. This platform enables the acquisition of data with high clinical correlation in ADME, drug–to–drug interaction studies, bridging the gap between preclinical and clinical stages.
With advanced LC-MS/MS-based bioanalysis, PhoenixBio Co., Ltd. provides a seamless workflow from plasma concentration measurement and metabolite identification to quantitative validation.
The company offers an integrated evaluation analysis covering pharmacokinetics, hepatotoxicity, and safety with flexibility to accommodate complex modalities such as oligonucleotide and middle-molecule therapeutics.
For compounds where hepatic metabolism is a development bottleneck—or where quantitative, reproducible exposure data are critical—PhoenixBio Co., Ltd. delivers unmatched analytical precision and consistency.
Japanese
