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| Summary | BioDuro-Sundia is a contract research, development, and manufacturing organization (CRDMO) with 30 years of expertise providing integrated drug discovery, development, and manufacturing services from target identification through IND submission. | Full-service CRO and CDMO with specialized competency centers in drug discovery, formulation development, GMP manufacturing, and bioanalytical services across Germany and France. |
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| Services | - Discovery Research
- Target Identification & Validation
- High-Throughput Screening
- Computational & In-Silico Drug Discovery
- Medicinal Chemistry
- In Vitro Pharmacology
- In Vitro ADME / DMPK
- Safety Pharmacology
- Genetic Toxicology
- Preclinical In Vitro Studies
- In Vivo Efficacy Models
- In Vivo PK / PD Studies
- GLP Toxicology
- Specialized & Large-Animal Models
- Preclinical In Vivo Studies
- Bioanalysis
- Biomarker Assays
- Flow Cytometry Services
- Analytical Method Development & Validation
- ICH Stability Studies
- Translational Research
- US FDA Regulatory Strategy
- China NMPA Regulatory Strategy
- Regulatory Affairs
- Immunogenicity Assays (ADA / NAb)
- Oncology Specialty Services
- Immunology & Inflammation Services
| - Bioinformatics & Data Science
- Genomics & Sequencing Services
- Oncology Specialty Services
- Translational Research
- ICH Stability Studies
- Analytical Method Development & Validation
- Regulatory Affairs
- Biostatistics & Statistical Programming
- Data Management & eClinical
- Clinical Operations
- Phase II Clinical Trials
- Phase I Clinical Trials
- Clinical Trial Services
- Biomarker Assays
- Bioanalysis
- In Vivo PK / PD Studies
- In Vitro ADME / DMPK
- In Vitro Pharmacology
- Preclinical In Vitro Studies
- Medicinal Chemistry
- High-Throughput Screening
- Discovery Research
- Target Identification & Validation
- Computational & In-Silico Drug Discovery
- Protein Engineering
- CMC Analytical Development
- Stability Testing & Storage
- Quality Control Testing
- Formulation Development
- Process Development
- Technology Transfer
- CMC Regulatory Submission Support
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| Modalities | - Small Molecule
- Biologics (Monoclonal Antibodies)
- Biologics (Other)
- Antibody-Drug Conjugate (ADC)
- Peptide
| - Small Molecule
- Biologics (Other)
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| Indications | - Oncology
- Immunology
- Neurology
- Metabolic
- Respiratory
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| Locations | - Headquarters, Irvine, California, United States
| - Headquarters & Drug Discovery, Neu-Ulm, Baden-Württemberg, Germany
- Bioanalytical Services, Neu-Ulm, Baden-Württemberg, Germany
- Headquarters & Bioanalytical Services, Neu-Ulm, Baden-Württemberg, Germany
- Headquarters, Neu-Ulm, Baden-Württemberg, Germany
- Drug Discovery Research, Berlin, Berlin, Germany
- Formulation Development & GMP Manufacturing, Sophia Antipolis, Provence-Alpes-Côte d'Azur, France
- Drug Discovery, Berlin, Berlin, Germany
- Formulation & GMP Manufacturing, Sophia Antipolis, Provence-Alpes-Côte d'Azur, France
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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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