Biomere is a preclinical contract research organization in Worcester, Massachusetts that presents itself as "A JOINN Company."[S1] It was spun out of the University of Massachusetts Medical School in 1996 and acquired in 2019 by JOINN Laboratories, a contract research organization based in China.[S2] One structural point should be settled before anything else: the company states on its own toxicology page that "the following toxicology services are offered by our parent company JOINN Laboratories,"[S3] whose facilities are in China. A US sponsor engaging Biomere for GLP toxicology should therefore establish where the study will actually be run. This profile summarizes the services, sites, stated compliance information, and company facts most relevant to US sponsors.
What runs in the United States
The Worcester site is described as focused on non-GLP work: pharmacology, pharmacokinetic and pharmacodynamic studies and early toxicology.[S4] Sponsors should determine which exploratory studies may be conducted outside the good laboratory practice regulation and which safety studies must fall within it. The second US site is in Richmond, California, operating as JOINN Laboratories CA Inc.[S5] Sponsors should confirm which of the two would run their work, because the compliance statements differ between them.
Where the GLP toxicology runs
The toxicology page states plainly that "the following toxicology services are offered by our parent company JOINN Laboratories,"[S3] listing the parent's facilities in Suzhou, Beijing, Wuzhou, Chongqing and Guangzhou.[S3] The parent states GLP status in several regimes, describing itself as inspected under US FDA GLP and certified or inspected under Chinese, OECD, Japanese and Korean regimes.[S6] 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.[S6] 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] For a US sponsor there are practical consequences beyond the regulation itself: before contracting, sponsors should document the test facility, the monitoring plan, the sample and data transfer process, the timeline, the applicable GLP regime and inspection responsibilities. None of that makes the arrangement unsuitable; it does mean the arrangement should be understood before contracting rather than discovered later.
Quality, compliance, and animal welfare (as stated by the company)
Compliance statements differ by site. The Worcester, Massachusetts facility is listed with AAALAC accreditation, an OLAW Animal Welfare Assurance, USDA registration and a DEA registration.[S5] The Richmond, California facility is listed with AAALAC, USDA and DEA but without an OLAW statement.[S5] Whether that reflects a real difference or an omission on the page is not explained, and a sponsor whose work is funded by the Public Health Service would need to resolve it. 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.
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.
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