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| Summary | Bioanalytical CRO specializing in pharmacokinetics, immunogenicity, biomarkers, and CMC analytics with 30+ years of experience and 1,100+ employees conducting 5M+ tests annually. | Global CRDMO platform providing integrated end-to-end contract research, development, and manufacturing services across discovery, preclinical, clinical, and commercial phases for small molecules, peptides, oligonucleotides, and biologics across 30+ countries. |
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| Services | - Bioanalysis
- LC-MS Bioanalysis (Small Molecule)
- Flow Cytometry Services
- Biomarker Assays
- Immunogenicity Assays (ADA / NAb)
- Virology Services
- Analytical Method Development & Validation
- ICH Stability Studies
- US FDA Regulatory Strategy
- EU EMA Regulatory Strategy
- Ligand-Binding Bioanalysis (Large Molecule)
| - Discovery Research
- Target Identification & Validation
- High-Throughput Screening
- Medicinal Chemistry
- Computational & In-Silico Drug Discovery
- Protein Engineering
- Preclinical In Vitro Studies
- In Vitro Pharmacology
- In Vitro ADME / DMPK
- Safety Pharmacology
- Genetic Toxicology
- Preclinical In Vivo Studies
- In Vivo Efficacy Models
- In Vivo PK / PD Studies
- GLP Toxicology
- Carcinogenicity Studies
- DART (Reproductive & Developmental Toxicology)
- Specialized & Large-Animal Models
- Bioanalysis
- LC-MS Bioanalysis (Small Molecule)
- Ligand-Binding Bioanalysis (Large Molecule)
- Immunogenicity Assays (ADA / NAb)
- Biomarker Assays
- Flow Cytometry Services
- Clinical Trial Services
- Phase I Clinical Trials
- Phase II Clinical Trials
- Phase III Clinical Trials
- Phase IV / Post-Marketing
- Data Management & eClinical
- Biostatistics & Statistical Programming
- Medical Writing
- Pharmacovigilance & Drug Safety
- Regulatory Affairs
- US FDA Regulatory Strategy
- EU EMA Regulatory Strategy
- Japan PMDA Regulatory Strategy
- China NMPA Regulatory Strategy
- Analytical Method Development & Validation
- ICH Stability Studies
- Translational Research
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| Modalities | - Small Molecule
- Biologics (Monoclonal Antibodies)
- Biologics (Other)
- Vaccine
| - Small Molecule
- Peptide
- Oligonucleotide
- Biologics (Monoclonal Antibodies)
- Biologics (Other)
- Antibody-Drug Conjugate (ADC)
- mRNA
- Cell Therapy
- Gene Therapy
- Vaccine
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| Indications | Data not yet provided. | - Oncology
- Immunology
- Neurology
- Psychiatry
- Metabolic
- Cardiovascular
- Infectious Disease
- Rare Disease
- Respiratory
- Dermatology
- Ophthalmology
- Gastroenterology
- Nephrology
- Women's Health
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| Locations | - Research Triangle Park Campus (US Headquarters), Durham, North Carolina, United States
- Morrisville Labs, Morrisville, North Carolina, United States
- Boston Laboratory, Boston, Massachusetts, United States
- San Diego Laboratory, San Diego, California, United States
- Hamburg Laboratory (EU Headquarters), Hamburg, Hamburg, Germany
- Brisbane Laboratory, Brisbane, Queensland, Australia
- Melbourne Laboratory (Australian Headquarters), Melbourne, Victoria, Australia
- Partner Labs, Beijing, Beijing, China
| - Headquarters, Shanghai, Pudong, China
- Global Operations, Asia, Europe, North America
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| Certifications | Data not yet provided. | Data not yet provided. |
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| Reviews | Review summary appears after site-level review signal gate opens. | Review summary appears after site-level review signal gate opens. |
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