Learn more about our clinical services platform including:
- Fully integrated drug development services supporting preclinical and clinical needs,
up to regulatory approval and commercial phases
- Clinical supply suitable from First in Human to Phase III, fully GMP-compliant and
with capacity to handle active ingredients classified up to OEB5 (OEL>0.5 µg/m³)
- Additional capabilities such as API, formulation development, sample management, PK and statistical analyses, and metabolism
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INDiGO,
Fact Sheets,
IND Enabling Studies/Preclinical Development,
Clinical Development
Learn more about our abuse liability services including:
- Compound characterization
- Pharmacological assessment
- Preclinical Behavioral studies
- Integration within a multidisciplinary full-scope clinical-enabling program with chemistry,
pharmacology, DMPK, safety assessment, regulatory and clinical support, all driven by our drug
development experts
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INDiGO,
Fact Sheets,
IND Enabling Studies/Preclinical Development
Learn more about INDiGO and Evotec's integrated preclinical development capabilities to de-risk and accelerate IND-enabling programs:
- Typically, drug candidates can be advanced from candidate selection to IND-submission in 48–52 weeks
- Our experienced team not only executes R&D projects, but also proactively contributes to your scientific strategy
- Clients can either opt for the full INDiGO platform or selected preclinical development and CMC components
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pre-clinical development,
INDiGO,
Fact Sheets,
IND Enabling Studies/Preclinical Development
Learn more about our pathology services including:
- GLP certification with highest quality standards and an impeccable regulatory inspection history
- Unparalleled flexibility with all capabilities in-house and under one roof
- ACVP/DECVP, MRCPATH, DECLAM, DECVCP qualified pathologists/clinical pathologists
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Pathology,
Fact Sheets,
IND Enabling Studies/Preclinical Development
Learn more about our safety assessment services including:
- Toxicology core capabilities
- Safety pharmacology (GLP) studies
- Genetic toxicology (GLP) studies
- Additional capabilities such as bioanalytical method development and GLP validation, DMPK, immunoassays, immunogenicity testing, immunotoxicology assays
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Tags:
INDiGO,
Fact Sheets,
ADME/DMPK,
IND Enabling Studies/Preclinical Development,
Toxicology & Safety
Learn more about Evotec's regulated LC/MS bioanalysis capabilities and expertise including:
- High quality service across all phases of pre-clinical and clinical drug development in compliance with GLP and GCP regulations
- More than 25 years of experience to perform LC/MS activities in a regulated environment
- Extensive bioanalytical method development expertise to meet the most demanding and challenging client needs
- Multidisciplinary collaboration enabling integrated solutions to accelerate the drug development process
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Fact Sheets,
Proteomics, Metabolomics & Biomarkers,
IND Enabling Studies/Preclinical Development,
Sample Management
Learn more about Evotec’s polymerase chain reaction (PCR) services including:
- Therapeutic modalities
- Sample management capabilities
- PCR applications
- Quantitative real time PCR (qPCR) and reverse transcription qPCR (RT-qPCR) applications, including copy number estimation assays, gene expression profiling and genotyping assaysRegulated PCR services
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Fact Sheets,
Proteomics, Metabolomics & Biomarkers,
IND Enabling Studies/Preclinical Development,
Sample Management
Learn more about our ligand binding assays and how they can support biological drug testing in a regulated environment, including:
- Regulated bioanalysis
- Immunogenicity
- Immunotoxicity
- Biomarkers (safety and efficacy)
- Clinical Pathology
- Sample Management
- Additional activities
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Tags:
Fact Sheets,
Proteomics, Metabolomics & Biomarkers,
IND Enabling Studies/Preclinical Development,
Toxicology & Safety,
Sample Management
Learn more about human pharmacokinetic prediction including:
- background information on the predictive model
- in vitro ADME data and structural data requirements for PK prediction
- data delivered for the PK prediction
- validation data for the predictive model
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Tags:
Fact Sheets,
ADME/DMPK,
Modelling and Simulation
The Hollow Fibre Infection Model (HFIM) is a dynamic in vitro system for the determination of PK/PD relationships between antimicrobial compounds and bacteria, fungi or viruses.
Evotec has developed its own dedicated state-of-the-art BSL2 facility offering it partners a bespoke in vitro PK/PD service tailored to advance their individual antimicrobial development programs.
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Tags:
Antibiotic Resistance,
infectious diseases,
Fact Sheets,
In vitro Biology,
Anti-Infectives
