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LibraMedicina, Inc.

Table of Contents

LibraMedicina, Inc. is a trusted CRO that has successfully completed IND applications in both the United States and Taiwan, receiving approval from the FDA and other regulatory authorities.
This section provides a detailed overview of the company’s non-clinical testing capabilities, example disease models, and representative study cases.
Please use this information as a reference when selecting a reliable partner for your non-clinical needs.

Features of LibraMedicina, Inc.'s Non-clinical Contract Services

Non-clinical testing services based on international guidelines

LibraMedicina, Inc. provides non-clinical studies in compliant with major regulatory guidelines, offering high-quality safety studies, pharmacology studies, and pharmacokinetic evaluations. Their in-vivo services support the development of both synthetic and biopharmaceutical products—through drug discovery, regulatory submission, product manufacturing and clinical testing.

GLP-compliant studies conducted by expert teams

The company offers a wide range of GLP safety studies, including general toxicity, repeated-dose toxicity, genotoxicity, reproductive and developmental toxicity, efficacy/pharmacology studies, safety pharmacology, and PK/PD/metabolism studies. These studies are conducted by highly experienced toxicologists, pathologists, and laboratory animal specialists at the company’s preclinical testing center. All studies undergo audits by an independent quality assurance unit to ensure full GLP compliance.

Comprehensive analytical services

Libra Medicina also provides bio-analytical testing services for biopharmaceutical medicine and small-molecule compounds.
Using LC-MS/MS and other advanced analytical technologies, the company offers a broad range of services, including protein characterization,structural analysis, physicochemical profiling, and identification of impurities related to manufacturing processes and final products.

3 Specialized Pre-clinical CROs for Advanced Drug Discovery

Partner Companies with LibraMedicina, Inc.

No information regarding partnered organizations was found on the official website.

Non-clinical Case Studies at LibraMedicina, Inc.

Pharmacokinetic Studies(PK)

LibraMedicina, Inc. provides professional PK/ADME evaluations and consulting in compliance with regulatory requirements.
Their capability includes analytical services in bridging study, preclinical pharmacokinetic studies, toxicokinetic evaluations, clinical PK studies, bioavailability (BA) and bioequivalence (BE) studies, and post-marketing pharmacokinetic assessments studies.

Reference: LibraMedicina, Inc. official website https://www.lmed.co.jp/%E5%8F%97%E8%A8%97%E3%82%B5%E3%83%BC%E3%83%93%E3%82%B9/%E9%9D%9E%E8%87%A8%E5%BA%8A%E5%8F%97%E8%A8%97%E3%82%B5%E3%83%BC%E3%83%93%E3%82%B9/%E8%9B%8B%E7%99%BD%E8%A7%A3%E6%9E%90-%E8%96%AC%E7%89%A9%E5%8B%95%E6%85%8B-%E7%94%9F%E7%89%A9%E5%AD%A6%E7%9A%84%E5%88%86%E6%9E%90/

Bioanalytical services (small-molecule compounds)

LibraMedicina, Inc.’s laboratory facility is equipped with state-of-the-art analytical instruments and provides testing in compliance with regulatory guidelines such as GLP.
Light-shielded testing environments are also available.
Services include co-development of analytic measurement, quantitative measurements, bioanalysis of parent drugs and metabolites, and elemental analysis.

Company Information

LibraMedicina, Inc. provides intermediary services for contract R&D and manufacturing of biopharmaceuticals and synthetic pharmaceuticals, development consulting, and coordination of contract manufacturing of functional foods(food with health-promoting benefit) and related products.

Address	Room704, Nihonbashi Life Science Building 2, 3-11-5 Nihonbashi-Honcho, Chuo-ku, Tokyo
Tel	03-6712-7668
Website	https://www.lmed.co.jp/

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

Consult study design and disease model development
with SMC Laboratories, Inc.

Consult SMC Laboratories
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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.

Consult Labcorp Holdings Inc.
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 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 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 Co., Ltd. delivers unmatched analytical precision and consistency.

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

Phoenix Bio.
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