What We Do

NonClinical Development Strategy

  • Integrated nonclinical program strategy from candidate selection to first-in-human studies
  • Optimal design to support early go/no-go decision points, risk minimisation and investment decisions
  • Optimal design to generate the right data to support rationale for dose determination for first-in-human studies
  • Design of individual in vitro and in vivo studies supported by the right PK-PD-ADA assays in line with the integrated strategic plan
  • Outsourcing and execution of studies with interpretation and communication of data to support successful regulatory approvals and seamless clinical development


  • Integrated non-clinical and clinical bioanalytical strategy in support of the PK/PD, Biomarker & Immunogenicity strategies
    • Appropriate assay formats & technologies to measure PK, PD, Biomarker and immunogenicity
    • Performance characteristics & quality levels depending on development phase (right assay at the right time)
  • Assay development, validation, sample analysis & integrated data interpretation
    • Ligand binding, LC-MS/MS, PCR and cell-based assays
    • Reagent selection
    • Assay design, management, trouble shooting and sourcing

PK/PD, Biomarkers & Immunogenicity

  • Integrated non-clinical and clinical PK/PD, Biomarker & Immunogenicity strategies
  • Understanding exposure-response relationships
  • Immunogenicity risk assessment
    • Design, management, interpretation and sourcing of studies to assess immunogenicity potential such as dendritic cell assays, MAPPs assay, T cell assay, in silico algorithms.
  • Integrated PK/PD, Biomarker & immunogenicity interpretation
  • Integrated Summary of Immunogenicity (ISI)

Toxicology / Safety Pharmacology

  • Early target safety profiling assessment (de-risking)
  • Species selection
  • Design, manage, interpret and source relevant safety assessment studies (in vitro & in vivo)
    • Investigative studies
    • Regulatory toxicology studies
  • Primate Reproductive, developmental & juvenile toxicity assessments (ePPND studies for example)
  • Immunotoxicology / immuno-oncology evaluation expertise
    • Immunology assays
    • Cytokine release Assays
    • ADCC & CDC assays
  • Bone physiology / pharmacology assessment expertise
  • Safety pharmacology assessment for biotherapeutics expertise
  • Product specific carcinogenicity risk assessment documents


  • Pathology support for animal models of disease
  • Histopathology (primary read and peer review)
  • Integrated interpretation of data
  • Immunohistochemistry method validation and interpretation
    • Target validation (on-target binding)
    • Off-target interactions (e.g. tissue cross-reactivity study)
    • Investigative study support – evaluating unexpected findings
  • Early Research and Discovery
    • Morphological characterisation of animal models
    • Histopathology of efficacy and early safety studies
  • GLP and Non-GLP Regulatory Toxicology Studies
    • Histopathology primary read, peer review & pathology working group
    • Integrated interpretation in the context of all study data
  • GLP and Non-GLP Investigative and Molecular Pathology
    • Target validation
    • Off-target interactions: Tissue Cross-Reactivity (TCR) studies
    • Investigation of unexpected findings in regulatory toxicology studies

Integrated risk assessment & communication

  • Full integration of all available data
  • First in human starting dose / dose escalation justification, based on pharmacology & toxicology data (in vitro & in vivo)
  • Assist in the preparation (writing and review) of non-clinical sections of submission documents including NDA/MAA/JNDA, IMPD, IB, IND, CTA and other expert reports
  • Provide support for non-clinical regulatory agency meetings worldwide

Additional Activities

  • Due Diligence
  • Training in Toxicology, Pathology, PK/PD & Bioanalytics etc..
  • CRO selection / auditing
  • Study monitoring
  • Scientific advisory board support