D2team
D2team provides peer-reviewed nonclinical services, offering tailored, creative, and effective solutions to help drug products progress through regulatory milestones and to market. The team has extensive experience in drug discovery, development, pharmacology, toxicology, and regulatory interactions, serving innovators, startups, investors, and pharmaceutical companies. They adopt a fully peer-reviewed project management approach, providing flexible in-house project teams for all stages of nonclinical drug development.
Industries
Nr. of Employees
small (1-50)
Services
Provision of a multidisciplinary nonclinical project team to plan and execute preclinical programs and prepare regulatory documentation.
Strategic advice on regulatory requirements, design and execution support for IND enabling studies, CRO selection and regulatory meeting preparation.
Development of translational plans including first-in-human dose guidance, biomarker selection for target engagement and patient stratification, and alignment of animal and clinical endpoints.
Authoring of nonclinical sections of regulatory submissions, briefing packages, safety reports and other regulatory documents for submissions worldwide.
Provision of a multidisciplinary nonclinical project team to plan and execute preclinical programs and prepare regulatory documentation.
Strategic advice on regulatory requirements, design and execution support for IND enabling studies, CRO selection and regulatory meeting preparation.
Development of translational plans including first-in-human dose guidance, biomarker selection for target engagement and patient stratification, and alignment of animal and clinical endpoints.
Authoring of nonclinical sections of regulatory submissions, briefing packages, safety reports and other regulatory documents for submissions worldwide.
Expertise Areas
- Nonclinical pharmacology
- Nonclinical safety and toxicology
- Regulatory submissions and scientific writing
- Translational science and biomarker strategy
Key Technologies
- GLP-compliant toxicology studies
- Juvenile animal models
- Biomarker development and validation
- Bioanalytical assays and drug metabolism studies