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North American Science Associates (NAMSA)

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North American Science Associates (NAMSA) is a global contract research organization (CRO) specializing in the medical device sector. Without relying on intermediary companies, NAMSA provides an extensive range of developmental support —including non-clinical studies—through fully integrated in-house models.

Features of NAMSA’s Contract Non-Clinical Testing Services

Global preclinical research environment and robust regulatory compliance

NAMSA conducts preclinical studies (GLP and non-GLP) at its Good Laboratory Practice (GLP)-compliant facilities. The organization emphasizes high-quality research operations supported by AAALAC accreditation and adherence to FDA regulatory standards.

For medical device development, NAMSA also offers biocompatibility study design aligned with guidelines such as the ISO 10993 series.

Comprehensive preclinical testing and advanced protocol development support

NAMSA performs a broad range of preclinical studies for medical device manufacturers, including safety, performance, efficacy, toxicity, and biocompatibility assessments. Services are delivered through a one-stop process encompassing study design, execution, and reporting.

The company also supports protocol pre-submission through the FDA Q-Submission program and develops appropriate study designs based on the intended device classification.

Regulatory strategy support and enhanced ethical and quality management systems

NAMSA supports a research framework that prioritizes ethical considerations, including adherence to the 3Rs principle, while following stringent quality assurance programs and standard operating procedures (SOPs). These practices ensure reliable studies and transparent data outputs.

The company can also prepare protocols that include detailed descriptions of animal models and statistical justification required for regulatory submissions for disease-related devices.

3 Specialized Pre-clinical CROs for Advanced Drug Discovery

Examples of NAMSA’s Disease Models

Extensive testing expertise in cardiovascular devices

NAMSA has significant experience conducting both preclinical and clinical studies for devices in the cardiac, cardiovascular, and neurovascular fields. As a specialized cardiovascular CRO, the company excels in evaluating device functionality and biocompatibility for valves, stents, and circulatory support systems.

Over the past five years, NAMSA has supported more than 300 cardiovascular projects across 30 countries. Its capabilities extend to a wide range of therapeutic devices, including coronary stents, left ventricular assist devices, and catheter-based systems. Strong clinical trial management supported by substantial monitoring experience further distinguishes NAMSA as a trusted partner in cardiovascular device development.

Reference: https://namsa.com/expertise/devices/cardiovascular/

NAMSA’s Non-Clinical Study Case Examples

No specific case studies were available on the official website.

Company Information

Address	3F, 3-7-2 Nihonbashi-Honcho, Chuo-ku, Tokyo
Tel	03-6803-5645
Website	https://namsa.com/

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 official website (https://www.smccro-lab.com/jp/)

SMC Laboratories 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 approachallows 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 is an ideal partner for start-ups, biotech ventures, and academic institutions alike.

Consult study design and disease model development
with SMC Laboratories

Consult SMC Laboratories
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Safety Studies
Comprehensive Safety Evaluation for FIH Applications

labcorp
(Labcorp Drug Development)

Reference: labcorp official website (https://jp.labcorp.com/)

labcorp 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’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.

Consult labcorp
Discuss GLP/ICH-compliant study design for your FIH submission.

To labcorp.
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Pharmacokinetic (PK/PD) Studies
High-Precision Bioanalysis for Clinically Predictive PK/PD Evaluation

PhoenixBio

Source: PhoenixBio Official Website (https://phoenixbio.co.jp/)

PhoenixBio 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 provides aseamless workflow from plasma concentration measurement and metabolite identification to quantitative validation.
The company offersan integrated evaluation analysiscovering 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 delivers unmatched analytical precision and consistency.

Consult Phoenix Bio for PK/PD analysis with a clinical focus

Phoenix Bio.
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