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 non-clinical development, the choice of contract research organization shapes the quality of the data and the time it takes to reach the next decision. Below, three CROs are introduced by the type of study they support: pharmacology (efficacy) studies, safety studies, and pharmacokinetic (PK/PD) studies. Each summary describes the services the company offers so that you can match a provider to your target and development objective.
Pharmacology (Efficacy) StudiesDisease-Relevant Models for Translational Drug Evaluation
Reference: SMC Laboratories, Inc. official website (https://www.smccro-lab.com/)
SMC Laboratories, Inc.
SMC Laboratories is a specialized non-clinical CRO focused on in vivo pharmacology and efficacy studies using disease-relevant animal models, particularly in fibrosis, inflammation, metabolic diseases, and oncology.
Areas of Expertise
Disease-Relevant Model Portfolio
SMC Laboratories offers models covering the liver, lung, kidney, intestine, and oncology. Its portfolio includes the proprietary STAM™ model for MASH, fibrosis, and hepatocellular carcinoma.
Study Design Based on Target Biology
Study plans are developed around the target biology, mechanism of action, disease stage, and development objective. Pharmacological endpoints can be combined with histopathology, biomarkers, and disease-specific readouts.
Support from Target Validation to Proof of Concept
With experience from more than 1,000 studies for clients in 30 countries, SMC Laboratories supports programs from target validation and candidate selection through in vivo proof-of-concept studies.
Safety StudiesComprehensive Safety Assessment for Preclinical Development
Reference: Charles River Laboratories official website (https://www.criver.com/)
Charles River Laboratories
Charles River provides non-clinical toxicology and safety assessment services for programs ranging from exploratory safety studies to IND-enabling development.
Areas of Expertise
General Toxicology Across Study Designs
Services include single- and repeat-dose toxicology, dose-range finding, and general toxicology studies across multiple species and administration routes.
Non-GLP and GLP Study Support
Charles River supports both non-GLP and GLP studies, allowing sponsors to progress from early safety characterization to studies intended for regulatory submissions.
Integrated IND-Enabling Safety Assessment
Toxicology studies can be integrated with toxicokinetics, clinical pathology, histopathology, and safety pharmacology to support interpretation and IND-enabling safety packages.
Pharmacokinetic (PK/PD) StudiesConnecting Drug Exposure with Pharmacological Response
Reference: Inotiv official website (https://www.inotiv.com/)
Inotiv
Inotiv provides integrated PK/PD, DMPK, and bioanalytical services to characterize drug exposure and its relationship with pharmacological response.
Areas of Expertise
Pharmacokinetic Characterization
PK studies characterize exposure, half-life, clearance, and other pharmacokinetic parameters needed to understand how a candidate behaves in the selected model.
Exposure–Response Evaluation
Pharmacokinetic data can be combined with pharmacodynamic endpoints and bioanalysis to evaluate the relationship between drug exposure and pharmacological response.
Integrated DMPK and Development Support
Integrated DMPK, pharmacology, and safety information supports candidate comparison, dose selection, dosing-frequency optimization, and decisions about subsequent preclinical development.
Japanese
