Learn more about how our INDiGO-Select services help in profiling and selecting your optimal clinical development candidate with:
- Enhanced quality profile, speed of delivery, and probability of success of clinical candidates
- Early identification of developability gaps and liabilities in selection process, enabling thorough
de-risking of your candidate with flexible advanced lead optimization approaches
- Managed by skilled discovery scientists and complemented by experienced drug development
experts in CMC and preclinical development all under one roof
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Fact Sheets,
IND Enabling Studies/Preclinical Development,
Toxicology & Safety,
Clinical Development
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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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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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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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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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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Fact Sheets,
Proteomics, Metabolomics & Biomarkers,
IND Enabling Studies/Preclinical Development,
Toxicology & Safety,
Sample Management
Don't miss our educational webinar. In-house expert, Ellenia Bordini, will cover various early stage "alternative approaches" for the evaluation of metabolites in human and preclinical species, and how these can be used to direct preclinical safety testing for regulatory submission.
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Videos & Webinars,
IND Enabling Studies/Preclinical Development
