Nelson Laboratories, LLC, which trades as Nelson Labs, is a testing laboratory in Salt Lake City, Utah and a business of Sotera Health Company (Nasdaq: SHC).[S1][S8] It describes itself as a global laboratory providing testing and advisory services for medical device, pharmaceutical, tissue and biologics companies."[S1] The scope matters: this is quality and safety testing of products, not pharmacology. No disease model efficacy testing, safety pharmacology package, DMPK service or drug bioanalysis was found on the pages reviewed. A drug developer would come here for biocompatibility, sterility assurance and extractables and leachables work, and for a combination product or device component of a program.
Services relevant to US drug and device developers
Biocompatibility and toxicology under ISO 10993
Biocompatibility is the biocompatibility service line. The company states that "the company describes cytotoxicity, sensitization and irritation as three common biocompatibility tests; sponsors should determine the endpoints required for their own device (often referred to as the Big Three): cytotoxicity, sensitization, and irritation tests,"[S4] and lists genotoxicity, hemocompatibility, systemic toxicity, implantation with histopathology and risk assessments alongside them, referencing ISO 10993-6, -10, -11 and -12.[S4] Some of these endpoints are in vitro; the bacterial endotoxin test, for example, is described as "an in vitro assay for detection and quantitation of bacterial endotoxins."[S6] Others involve animals: the implantation test page states that "gross necropsy observations will be made and implant sites are harvested and prepared for pathology review."[S5] Sponsors should be clear which endpoints in their package are animal-based, both for planning and for the questions in the compliance section below.
Sterility assurance, extractables and leachables, and microbiology
Sterility assurance covers product sterility testing in rapid, isolator and cleanroom formats, the bacterial endotoxin test and its recombinant version, biological indicator sterility testing and container-closure integrity.[S6] The wider testing menu adds sterilization validation, extractables and leachables with material characterization screens, packaging solutions including shelf-life studies, facility and process validation, protective barrier testing, reusable medical device processing and chemistry testing, referencing ISO 10993-17 and -18, USP chapter 661, and AAMI and ASTM standards.[S7] Antimicrobial and disinfectant efficacy testing and clinical and environmental microbiology, including microbial identification, bioburden, environmental monitoring and mycoplasma testing, are quality control microbiology rather than therapeutic infectious disease research.[S7] Pharmaceutical chemistry testing and method development are offered separately.[S10]
Quality, compliance, and animal welfare (as stated by the company)
Quality accreditations. The company's US sites list ISO/IEC 17025 accreditation, ISO 9001, FDA Accreditation Scheme for Conformity Assessment participation and FDA facility registrations.[S7] No statement naming 21 CFR Part 58 or another GLP regulation was found on the pages reviewed, so a sponsor needing a GLP study should confirm scope and regulation directly.[R2]
No AAALAC, USDA, OLAW or IACUC statement was found on the pages reviewed; that is an absence in those pages, not a finding about the status of the company. The company's own test pages describe animal-based procedures: dosing for systemic toxicity, skin reaction observation for sensitization and irritation, and surgical implantation followed by necropsy.[S4][S5] Despite that, no AAALAC accreditation, USDA registration, OLAW Animal Welfare Assurance or Institutional Animal Care and Use Committee statement appears on any page reviewed. [S6] Sponsors with animal welfare requirements should request the oversight documentation directly rather than infer 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]
6280 S. Redwood Rd., Salt Lake City, UT 84123, United States[S1]
Founded
1985, by Dr. Jerry R. Nelson and Lynda S. Nelson[S2]
Ownership
A business of Sotera Health Company (Nasdaq: SHC), which goes to market through Sterigenics, Nordion and Nelson Labs[S8]
Employees (company statement)
More than 1,100, of whom more than 700 are scientists[S2]
Sites
12 locations across the United States, Mexico, Europe and China, including Salt Lake City UT, Itasca IL, Ontario CA and Leuven in Belgium[S2][S3]
Segment revenue
$220.2 million in fiscal 2025, against $229.2 million in 2024 and $221.7 million in 2023, per Sotera Health segment reporting[S9]
Service scope
Biocompatibility and toxicology, sterility assurance, sterilization validation, extractables and leachables, packaging, facility and process validation, microbiology, chemistry testing, regulatory advisory[S7]
Not offered
Disease model efficacy studies, safety pharmacology, DMPK and drug bioanalysis were not found on the pages reviewed[S7]
Standards named
ISO 10993 series, USP chapter 661, AAMI and ASTM; ISO/IEC 17025 and ISO 9001 for the laboratories[S4][S7]
GLP, AAALAC, USDA, OLAW
No statement found on the pages reviewed
Past acquisition
Toxikon Europe N.V. acquired on October 31, 2017, forming Nelson Labs Europe[S2]
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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