T3 Labs is a preclinical laboratory in Atlanta, Georgia, and since December 14, 2023 it has been part of Veranex, a contract research organization focused on medical devices and diagnostics.[S1][S2][S8] It is not a separate company today. The website presents it as a facility and brand within Veranex preclinical services, and no separate legal entity or independent financial disclosure was found.[S1] What the site does describe in detail is the work: large-animal studies for implanted and interventional devices, run under both the United States and the international good laboratory practice frameworks, in a building with functioning operating rooms and a catheterization laboratory.[S3][S5] Sponsors searching for the older name will find the same facility here.
Services relevant to US device and combination product developers
Species and models
Large animal models are the centre of the offering: swine, both farm breeds and minipigs, sheep, cattle and goats, with mice, rats, rabbits and guinea pigs available for smaller-scale work.[S3] Named disease models include heart failure, acute myocardial infarction, vascular pathology and bone defects, and a specialized model using pregnant ewes supports fetal intervention work.[S3] That last capability is unusual and narrows the field considerably for any programme in maternal-fetal devices. Study results in these models describe device performance in the animal; they do not by themselves establish a clinical benefit in people.
Therapeutic areas and study support
The named therapeutic areas on the preclinical services page are cardiovascular, vascular intervention, neurosurgery and neuromodulation, targeted drug delivery, gastroenterology and urology, orthopaedics, maternal-fetal health, ophthalmology, and regenerative medicine and wound healing.[S3] The T3 Labs page separately cites twelve therapeutic areas without naming them, so only the named list is reproduced here.[S1] Study support includes protocol development, regulatory consultation, in-house gross pathology and histopathology, post-study pathology consultation, medical writing of final reports, quality assurance, and imaging including computed tomography, magnetic resonance, echocardiography and intravascular imaging.[S3] Biocompatibility testing and device performance validation are listed as study types.[S3]
The facility
The Atlanta site is described as 33,000 square feet, located in the Science Square life sciences district.[S1] Facilities listed include three functioning operating rooms and a full catheterization laboratory equipped with operating tables, lighting and general instrumentation, with hybrid rooms offering three-dimensional rotational angiography.[S5] The same suites support surgical and procedural training alongside study work.[S5] Veranex preclinical services also operate a site in Paris and a pathology laboratory in Worcester, so a sponsor should confirm which site will run each part of a package.[S3][S4]
Quality, compliance, and animal welfare (as stated by the company)
Two good laboratory practice pathways are named explicitly: studies to the United States regulation at 21 CFR Part 58 for submissions to the Food and Drug Administration, and studies certified under the OECD principles for the European pathway.[S3][S4] The company names 21 CFR Part 58, the OECD principles in its GLP statement.[S4] 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] Naming both frameworks is useful for a programme that will be filed on both sides of the Atlantic, since the study has to be designed for the applicable one from the start rather than converted afterwards.
On animal work, the company states that both the Atlanta and Paris facilities are fully accredited by AAALAC International, and lists United States Department of Agriculture registration, a Public Health Service Assurance and Drug Enforcement Administration registration among the credentials of the good laboratory practice facility.[S3][S4] Twenty full-time veterinarians are cited, including board-certified specialists.[S3] The literal term for the institutional animal care and use committee was not found on the pages reviewed, although veterinary oversight is described at length; that absence is from those specific pages only. 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 animal care programme.
Two marketing claims are worth separating from the verifiable material. The company states a 95 percent good laboratory practice study success rate,[S3] without defining what counts as success, over what population or period. And the T3 Labs page states that more than 60 products were approved by the Food and Drug Administration over the past ten years, without describing the extent of the laboratory involvement in each.[S1] Approval attaches to a product, not to the laboratory that ran a study, and FDA does not approve or certify testing facilities.[R6] Both statements are recorded here as the company own. The site also cites successful FDA audits, dated 2013 in Paris and 2018 in Atlanta.[S4]
Ownership and continuity
Veranex was founded in 2021, is headquartered in Raleigh, North Carolina, and describes more than 800 specialists across fifteen international hubs.[S6] Two points bear on continuity. Leadership has turned over quickly: the press release announcing the T3 Labs acquisition names one chief executive, and a new chief executive was appointed in March 2026 after an interim period.[S2][S7] And the investor group named in the 2023 and 2024 announcements does not appear in the 2025 and 2026 announcements, which describe the company without naming backers.[S2][S7] Whether ownership changed could not be determined from the pages reviewed. Neither point says anything about the quality of the work at the Atlanta site, but both are the kind of thing a sponsor placing a multi-year programme would want to ask about directly.
Facility facts
Status
A facility and brand within Veranex preclinical services; no separate legal entity is described[S1]
Location
Science Square district, Atlanta, Georgia; no street address is published[S1]
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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