TransPharm Preclinical Solutions, Inc. is a small infectious disease specialist in Jackson, Michigan. It was founded in 2008 by Daniel Ross and remains privately and family held.[S2] Its scope is narrow and clearly stated: rodent efficacy models of infection, supported by in vitro microbiology, run in its own vivarium.[S3][S4][S5] Two points shape how a sponsor should read it. The facility is biosafety level 2, not level 3, so agents requiring higher containment are out of scope.[S3] And the company publishes its animal welfare credentials in unusual detail, including accreditation and assurance numbers.[S7] This profile summarizes the services, facility, stated compliance information, and company facts most relevant to US sponsors.
Services relevant to US drug developers
In vivo infection models and in vitro microbiology
The company runs efficacy models of infection in mice and rats, with pharmacokinetic blood sampling available alongside the efficacy readouts.[S4] In vitro microbiology, including minimum inhibitory concentration determination, supports compound triage before animal work.[S5] Only mice and rats are used; no larger species are offered, which keeps the model set within what a BSL-2 facility can support.
Pathogen coverage
The homepage cites more than 50 pathogens,[S1] while the pathogen listing page names 34 individually.[S6] Both figures are reproduced here as published; the gap may reflect strains held but not listed, or a figure that has not been updated. Sponsors should confirm that the specific organism and strain for their program is available, and that it can be handled at biosafety level 2.
The facility
The vivarium is described as AAALAC accredited and operating at biosafety level 2, with nine bioBubble isolation cabins.[S3] Isolation cabins matter in infection work because they allow several studies with different organisms to run at once without cross-contamination, which is often the practical constraint on scheduling at a small site. Unlike consortium or brokerage models, TransPharm houses the animals itself, so the accreditation and assurance below apply to the facility that will actually run the study.
Quality, compliance, and animal welfare (as stated by the company)
Accreditation and assurance numbers are published. The company states AAALAC accreditation held since October 2009 under file number 001301, and a PHS Animal Welfare Assurance with the Office of Laboratory Animal Welfare held since June 2014 under assurance number A4707-01, together with the composition of its Institutional Animal Care and Use Committee.[S7] Publishing the file and assurance numbers lets a sponsor check the status against the issuing bodies' own records rather than taking the claim on trust, which is more than most sites in this list provide. 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.
GLP is not claimed. No GLP statement was found on the pages reviewed, and no USDA registration statement appears for the facility itself; USDA is mentioned only in the founder's prior career description.[S2][S7] A facility working only with mice and rats may fall outside Animal Welfare Act registration requirements, but that is a determination for the company and the agency rather than an inference to be drawn here. Sponsors needing a GLP study should confirm scope and regulation directly.[R2]
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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