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| Summary | Certara transforms drug development with proprietary biosimulation software, predictive modeling, and AI-driven services spanning discovery through commercialization. Serving 2,400+ biopharmaceutical companies and regulatory agencies across 70 countries, Certara's model-informed drug development (MIDD) platform accelerates clinical and regulatory decision-making. | Innovation-led CRDMO offering integrated scientific services from early discovery through commercial manufacturing, with cGMP-compliant facilities, 5,200+ scientists, and a new 50,000-liter single-use bioreactor capacity in the U.S. |
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| Services | - Biostatistics & Statistical Programming
- Data Management & eClinical
- Regulatory Affairs
- Medical Writing
- Computational & In-Silico Drug Discovery
- Translational Research
- Target Identification & Validation
- High-Throughput Screening
- Medicinal Chemistry
- In Vitro Pharmacology
- In Vitro ADME / DMPK
- Safety Pharmacology
- Genetic Toxicology
- Discovery Research
- In Vivo Efficacy Models
- In Vivo PK / PD Studies
- GLP Toxicology
- Preclinical In Vitro Studies
- Preclinical In Vivo Studies
- Bioanalysis
- LC-MS Bioanalysis (Small Molecule)
- Ligand-Binding Bioanalysis (Large Molecule)
- Phase I Clinical Trials
- Biomarker Assays
- Phase II Clinical Trials
- Phase III Clinical Trials
- Clinical Operations
- Phase IV / Post-Marketing
- US FDA Regulatory Strategy
- US FDA Regulatory Strategy
- EU EMA Regulatory Strategy
- EU EMA Regulatory Strategy
- Japan PMDA Regulatory Strategy
- Japan PMDA Regulatory Strategy
- China NMPA Regulatory Strategy
- China NMPA Regulatory Strategy
- Clinical Trial Services
| - Discovery Research
- Medicinal Chemistry
- Computational & In-Silico Drug Discovery
- In Vitro Pharmacology
- In Vitro ADME / DMPK
- Safety Pharmacology
- GLP Toxicology
- Analytical Method Development & Validation
- Formulation Development
- Process Development
- CMC Analytical Development
- Small Molecule Development & Manufacturing
- API Synthesis & Manufacturing
- Sterile Fill-Finish & Aseptic Manufacturing
- Vial Filling
- Prefilled Syringe (PFS) Filling
- Cell-Line Development
- Recombinant Protein Manufacturing
- Monoclonal Antibody (mAb) Manufacturing
- Biologics Development & Manufacturing
- Upstream Processing
- Downstream Processing
- Bioanalysis
- Peptide Manufacturing
- Oligonucleotide Manufacturing
- ADC (Antibody-Drug Conjugate) Manufacturing
- Cell Therapy Manufacturing
- mRNA Manufacturing
- Translational Research
- High-Throughput Screening
- Genetic Toxicology
- Preclinical In Vitro Studies
- Preclinical In Vivo Studies
- In Vivo Efficacy Models
- In Vivo PK / PD Studies
- Carcinogenicity Studies
- DART (Reproductive & Developmental Toxicology)
- Specialized & Large-Animal Models
- 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
- Clinical Operations
- Data Management & eClinical
- Biostatistics & Statistical Programming
- Pharmacovigilance & Drug Safety
- Medical Writing
- Central Laboratory Services
- Clinical Imaging Core Lab
- Regulatory Affairs
- US FDA Regulatory Strategy
- EU EMA Regulatory Strategy
- Japan PMDA Regulatory Strategy
- China NMPA Regulatory Strategy
- ICH Stability Studies
- Companion Diagnostics Development
- Microbiology Services
- Virology Services
- Immunology & Inflammation Services
- Oncology Specialty Services
- CNS Specialty Services
- Cardiovascular & Metabolic Specialty Services
- Pathology & Histology Services
- Genomics & Sequencing Services
- Proteomics Services
- Bioinformatics & Data Science
- Device & Combination Product Services
- HPAPI Manufacturing (High-Potency)
- Controlled Substance Manufacturing
- Flow Chemistry & Continuous Manufacturing
- Solid-State Chemistry & Polymorph Screening
- Microbial Fermentation
- ADC Payload & Linker Synthesis
- Bioconjugation Services
- Viral Vector Manufacturing
- AAV Manufacturing
- Lentiviral Vector Manufacturing
- Autologous Cell Therapy Manufacturing
- Allogeneic Cell Therapy Manufacturing
- Lipid Nanoparticle (LNP) Formulation
- Vaccine Manufacturing
- Microbiome / Live Biotherapeutic Manufacturing
- Cartridge Filling
- Lyophilization (Freeze Drying)
- Oral Solid Dosage Manufacturing
- Topical & Semi-Solid Manufacturing
- Inhalation & Nasal Dosage Manufacturing
- Ophthalmic Manufacturing
- Technology Transfer
- Quality Control Testing
- Stability Testing & Storage
- Extractables & Leachables Studies
- Secondary Packaging & Labeling
- Serialization & Track-and-Trace
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| Modalities | - Small Molecule
- Small Molecule
- Biologics (Monoclonal Antibodies)
- Biologics (Monoclonal Antibodies)
- Biologics (Other)
- Biologics (Other)
- Peptide
- Peptide
- Oligonucleotide
- Oligonucleotide
- mRNA
- mRNA
- Antibody-Drug Conjugate (ADC)
- Antibody-Drug Conjugate (ADC)
- Gene Therapy
- Gene Therapy
- Cell Therapy
- Cell Therapy
- Vaccine
- Vaccine
| - Small Molecule
- Biologics (Monoclonal Antibodies)
- Biologics (Other)
- Peptide
- Oligonucleotide
- Antibody-Drug Conjugate (ADC)
- Cell Therapy
- mRNA
- Gene Therapy
- Vaccine
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| Indications | - Oncology
- Rare Disease
- Immunology
- Immunology
- Neurology
- Neurology
- Psychiatry
- Metabolic
- Metabolic
- Cardiovascular
- Cardiovascular
- Infectious Disease
- Infectious Disease
- Respiratory
- Respiratory
- Dermatology
- Dermatology
- Ophthalmology
- Ophthalmology
- Gastroenterology
- Gastroenterology
- Nephrology
- Nephrology
- Women's Health
- Women's Health
| - Rare Disease
- Oncology
- Immunology
- Neurology
- Psychiatry
- Metabolic
- Cardiovascular
- Infectious Disease
- Respiratory
- Dermatology
- Ophthalmology
- Gastroenterology
- Nephrology
- Women's Health
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| Locations | - Global network
- Global presence, 30 countries
- Global presence, Multiple, 30 countries, Global
- Global presence, Multiple, 30+ countries
- Global presence, Multiple, 30 countries, International
- Headquarters, Radnor, Pennsylvania, United States
- Global presence, 30 countries
- Global presence, 30+ countries
| - Headquarters, Bangalore, Karnataka, India
- U.S. Biologics Facility, United States
- U.S. Biologics Facility, San Diego, California, United States
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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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