The Drug Development Team offers a wide range of services covering all stages of drug development.

We offer support in:

  • A full all-round nonclinical project team
    • Program design and execution/SME support
    • Pharmacology and toxicology study design
    • Pediatric and juvenile development support
    • Contract Research Organisation (CRO) selection and Study monitoring
    • Environmental Risk Assessments (ERA), impurity assessments, cleaning limits
  • Investigational New Drug (IND) enabling project support
    • Regulatory engagement and documentation
  • Translational science
    • Support in clinical biomarker strategy
    • Support in evaluating clinical relevance
    • Support in First-in-Human (FiH) preparation and safe first dose guidance
  • Project evaluation 
    • Including repurposing
    • Due diligence preparation and evaluation
  • Scientific and regulatory writing
    • Investigational New Drug (IND), Marketing Authorization Application (MAA), Investigator’s Brochure (IB), study protocols & reports, scientific advice packages

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