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.
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.
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.
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.
No information regarding partnered organizations was found on the official website.
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.
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.
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/ |
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.
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.
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 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.
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.
Charles River provides non-clinical toxicology and safety assessment services for programs ranging from exploratory safety studies to IND-enabling development.
Services include single- and repeat-dose toxicology, dose-range finding, and general toxicology studies across multiple species and administration routes.
Charles River supports both non-GLP and GLP studies, allowing sponsors to progress from early safety characterization to studies intended for regulatory submissions.
Toxicology studies can be integrated with toxicokinetics, clinical pathology, histopathology, and safety pharmacology to support interpretation and IND-enabling safety packages.
Inotiv provides integrated PK/PD, DMPK, and bioanalytical services to characterize drug exposure and its relationship with pharmacological response.
PK studies characterize exposure, half-life, clearance, and other pharmacokinetic parameters needed to understand how a candidate behaves in the selected model.
Pharmacokinetic data can be combined with pharmacodynamic endpoints and bioanalysis to evaluate the relationship between drug exposure and pharmacological response.
Integrated DMPK, pharmacology, and safety information supports candidate comparison, dose selection, dosing-frequency optimization, and decisions about subsequent preclinical development.