Noble Life Sciences is a preclinical contract research organization (CRO) located in Sykesville, Maryland. The company describes itself as "a full-service preclinical contract research organization offering GLP and non-GLP services, including safety and efficacy testing, for the development of drugs, vaccines, and medical devices,"[S2] and states on its homepage that it is "American Owned & Operated" and that all studies are performed in the United States.[S1] This profile summarizes the services, facilities, stated compliance information, and company facts most relevant to US sponsors.
Nonclinical services relevant to US drug developers
Efficacy models: oncology, infectious disease, and metabolic disease
The Therapeutics section of the website lists oncology models (syngeneic mouse models, patient-derived xenograft (PDX), xenograft, and orthotopic tumor models) with study areas in immuno-oncology, vaccines, small molecules, and cell and gene therapy;[S5] infectious disease efficacy testing for antiviral and antibacterial candidates and vaccines, including work with "BSL2 and BSL3 agents";[S5] and diabetes work described as "Preclinical models to identify markers of type 1 and type 2 diabetes," together with testing of stem cell-based and gene therapy products.[S5] The species listed on the medical device page are mice, rats, guinea pigs, hamsters, rabbits, and ferrets among small animals, and sheep, goats, domestic swine, and mini-pigs among large animals.[S8]
Toxicology and cell and gene therapy support
Noble offers GLP and non-GLP toxicology described as "Assistance for planning and executing preclinical studies and IND submissions," listing local and systemic toxicity, histopathology, blood cytokine analysis, and pharmacodynamic marker analysis as study components.[S7] For cell and gene therapy programs the company lists biodistribution and shedding, toxicology, flow cytometry, immunoassays, efficacy, insertion site analysis, transgene characterization, and real-time PCR.[S6] On its compliance page the company states: "With decades of GLP experience, our scientists can support all aspects of the GLP process, from design to regulatory support of your IND, IDE, or PMA FDA submission."[S4] An IND is not "approved" by FDA: under 21 CFR 312.40 it goes into effect 30 days after FDA receives it unless FDA imposes a clinical hold.[R1] A CRO may conduct and report nonclinical studies that a sponsor includes in an IND, but it cannot guarantee that FDA will allow the clinical investigation to proceed. For work supporting an Investigational Device Exemption or a Premarket Approval application, confirm in the proposal which nonclinical studies Noble will conduct and which submission deliverables it will provide: the CRO generates and reports the nonclinical data, and FDA makes the regulatory decision.
Medical device testing
The company states that it "offers a wide range of non-GLP and GLP testing services to ensure the efficacy and safety of your medical device technologies."[S8] Device models are grouped on the website as cardiovascular (myocardial infarction, thrombosis, microvascular surgery), orthopedics (joint, bone defect, spinal fusion), trauma (traumatic injury, hemostasis), wound healing (full-thickness wound, burn, skin graft), and drug delivery (implantable pumps, patches, infusion systems).[S8] Imaging equipment listed includes IVIS optical imaging for live-animal imaging, C-arm fluoroscopy with radiographic and interventional radiology capability, and ultrasound.[S8]
Facilities
The company describes "24,000 square feet of animal housing, support, and laboratory space securely situated in a twenty-five acre campus" in Sykesville, Maryland, made up of 8,000 square feet of conventional and 14,000 square feet of specific pathogen free (SPF) housing and support space.[S3] Stated capacity is more than 10,000 rodents, more than 1,000 rabbits and ferrets, and more than 100 pigs, sheep, and goats.[S3] BSL-2 work is performed on the Sykesville campus, and the company lists a BSL-3 facility for SARS-CoV-2 work at George Mason University in Manassas, Virginia.[S3]
Quality, compliance, and animal welfare (as stated by the company)
GLP. The compliance page states: "Through functional quality systems and experienced quality personnel, we provide research integrity and regulatory compliance with US CFR Title 21 Part 58."[S4] The company names FDA 21 CFR Part 58 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] The company also states that it has "over 15 years of experience with vaccine, medical device and drug manufacturers to conduct GLP submissions."[S2]
Accreditation, registration, and inspection. The facilities page states: "Since 1989, our facilities have been accredited by the Association for the Assessment and Accreditation of Laboratory Animal (AAALAC),"[S3] and the compliance page displays the labels "AAALACi Accredited," "USDA Licensed," "FDA Inspected," and "OLAW Assured."[S4] No registration or Assurance numbers and no inspection dates are shown. The "FDA Inspected" label is the company's own description: FDA inspects nonclinical laboratories under its Bioresearch Monitoring program, but it does not approve or certify laboratories, so an inspection history is not an FDA endorsement.[R6] 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]
Animal welfare. The company states that it maintains an Institutional Animal Care and Use Committee (IACUC) "with standard five-day protocol review and approval" and that it complies with the Animal Welfare Act.[S3] No statement using the 3Rs terminology (replacement, reduction, refinement) was found on the pages reviewed. This profile does not evaluate the company's animal care program; the statements above are the company's own.
Company facts
Company name
Noble Life Sciences (the corporate suffix is not shown on the website)[S1]
Headquarters
1500 Fannie Dorsey Rd, Sykesville, MD 21784, United States[S3]
"American Owned & Operated" (company statement); no parent company or investor is named on the website[S1]
History
Founding year not stated; the company cites "Over 25 years of experience in the industry" and more than 15 years of GLP submission work with vaccine, medical device, and drug manufacturers[S2]
Facility
24,000 sq ft (8,000 sq ft conventional and 14,000 sq ft SPF) on a 25-acre campus; BSL-2 on site[S3]
BSL-3 satellite
George Mason University, Manassas, VA (SARS-CoV-2 work)[S3]
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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