Marubeni Chemix is a specialized non clinical CRO(contract research organization). They offer viral safety evaluation and many more. They provide smooth execution of high-quality non-clinical testing with their partnered GLP-compliant facilities in Japan.
Marubeni Chemix serves as the primary point of contact and manages all communication with partnered laboratories, such as LabCorp and RIAS (Research Institute for Biological Sciences and Safety).
Studies are conducted both in Japan and global partnered facilities. They serve as a lieson between clients and those facilities. This provides their clients a relief through all stages of processes—contracts, study requests, and reporting all can be done in Japanese. This significantly reduces the burden of English documentation and time-zone-related miscommunication.
The company supports a wide range of non-clinical studies and various stages od R&D, including toxicity, pharmacokinetics, safety pharmacology, and carcinogenicity.
Evaluations in the early drug discovery stage, such as lead optimization and candidate selection are also available.
Marubeni Chemix has established an integrated framework that enables consistent support from screening through IND submission. Flexible study design and high implementation accuracy are among their strengths.
Through our partnership with LabCorp, Marubeni Chemix can provides studies for small-molecules, next-generation modalities, such as biopharmaceuticals, cell and gene therapies, and vaccines. LabCorp can also provide optimized study designs for high-molecular-weight compounds and has extensive experience with GLP-compliant toxicology and bridging studies for global regulatory submissions.
This robust support system is especially suitable for companies who are developing innovative modalities.
RIAS is a testing and research organization staffed by nationally certified veterinarians, pharmacists, clinical laboratory technologists, and specialists in agriculture, chemistry, and biology.
For nearly 40 years, the institute has conducted a wide scope of GLP-compliant studies, including toxicity and safety testing for veterinary drugs, feed additives, and chemical substances, as well as microbiological testing, pharmacological evaluations, and clinical studies.
RIAS is the only certified facility in Japan for rabies antibody testing and is highly trusted by pharmaceutical companies and regulatory authorities. The institute is also active in supporting regulatory submissions and conducting academic research.
Reference: https://www.riasbt.jp/pages/19/
Marubeni Chemix coordinates viral clearance studies for biologically derived products as part of non-clinical viral safety evaluation. These studies validate the virus inactivation and removal processes to ensure product quality and safety.
All studies are conducted at GLP-compliant facilities in Japan, enabling the procuring of reliable, guideline-compliant data. Support is also available for preparing study reports for overseas regulatory submissions.
Reference:Labcorp Holdings Inc.
:https://www.marubenichemix.co.jp/service/copy_service_03.html
| Address | 7F & 11F, Sumitomo Fudosan Kanda Building, 7 Kanda Mitoshiro-cho, Chiyoda-ku, Tokyo |
|---|---|
| Tel | 03-4360-3400 |
| Website | https://www.marubenichemix.co.jp/index.html |
| Address | 3-7-11 Hashimotodai, Midori-ku, Sagamihara, Kanagawa |
|---|---|
| Tel | 042-762-2775 |
| Website | https://www.riasbt.jp/en/ |
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.