Services

Pharmaceuticals

Features of Pharmaceutical Services

Quality Assurance System（Pharmaceutical Business）

Cell and gene therapies

Quality evaluation of regenerative medicine

Microbiological evaluation, including virus safety testing of regenerative medicine

Rapid Sterility Test

Quality evaluation of gene therapy products

Karyotype analysis

Nucleic Acids, Peptides, and mRNAs

Quality and Stability Testing of Oligonucleotide Medicines

Impurity Profiling of Oligonucleotide Medicines by Two-Dimensional LC-MS/MS

Quality and Stability Testing of mRNA Drug Substances

Quality and Stability Testing of LNP Formulations of mRNA

Antibodies, ADCs, and Proteins

Biopharmaceutical Characterization, Quality Testing, and Stability Testing : Antibodies, ADCs (Antibody-Drug Conjugates), Bispecific Antibodies, and so on

mFISH and FISH (mFISH/FISH) analysis Monoclonality evaluation of cell lines for biopharmaceutical production

Small Molecules

Structural analysis of impurities in pharmaceuticals

Stability studies

Elemental Impurity Analysis (ICH Q3D)

Regulatory Science

Biomarker Analysis

Comprehensive Biomarker Analytical Services from Drug Discovery through Clinical Development

Biomarker Assays Using the Rapid, Hands-free Simple Plex (Ella™)

Exosome Research Services: Biomarkers for Drug Development

High-Purity Isolation and Biomarker Analysis of Circulating Tumor Cells (CTCs)

Measurement and Data Analysis Services Using Liquid Biopsy

Bioanalysis

GLP- and ICH M10-Compliant Bioanalysis for a Wide Range of Modalities in Nonclinical and Clinical Studies

Wide Range of Bioanalysis and Immunogenicity Assessment Services for Large-Molecule Drugs

Bioanalysis of Antibody-Drug Conjugates (ADCs)

Bioanalysis for Biopharmaceuticals Using the Gyrolab™ xP Workstation

Analytical Method Development for Antibody-Based Drugs in Biological Samples using LC-MS/MS

Bioanalysis for Nucleic Acid Drugs Using Low-Adsorption LC–MS/MS

Bioanalysis for Peptide Drugs Using Low-Adsorption LC–MS/MS

Bioanalysis for Small-Molecule Drugs Using LC–MS/MS

Analytical Support on Drug-Drug Interaction Evaluation for your Clinical Development

Exploratory Evaluation in Drug Discovery Stage

Supporting the Improvement of Your Success Rate in Drug Development with Our Advanced In Vitro and In Vivo Pharmacokinetic Studies

Service for the Medical Field

Testing Services for Advanced Medical Therapies

Rapid Microbiological Testing for Specific Processed Cells

Exosome Quality Evaluation Services

Expanded Newborn Screening

Expanded Newborn Screening

Services to support registration application

Registration application on Chemicals

Multi-Regional Approach：Tailor-Made to Your Needs

Japan

Application service for the Chemical Substances Control Law

Japan Industrial Safety and Health Act (ISHA) - New Chemical Substance Notification Support Service

Polymer under Kashinho (Japanese Chemical Substances Control Law, CSCL)

Registration Application in EU

EU / REACH

China and Taiwan

China：24-hour Emergency Service for GHS Labels of Chemical Substances

China：Services for Hazardous Chemicals to be imported into China

China New Chemical Substance Registration Support Services

Registration Application in Korea

Notification Services of Existing Chemical Substance in Korea

Notification Services of New Chemical Substance in Korea

Chemical Compliance Support

Hazzard Assessment

Eco-toxicity Studies

Hazardous Properties and Safety Assessment

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