Non-clinical services

 Our services include:

- Non-clinical assessments
        - Module 2.4 Non-clinical overview
        - Module 2.6 Non-clinical written and tabulated summaries

- Designing and planning of the toxicology programme, including study monitoring

- Non-clinical data review /data gap analysis

- Toxicological assessment of elemental impurities acc. to ICH Q3D

- Assessment of impurities acc. to ICH M7, including computational screening using
  multiple in silico tools ((Q)SAR)

- Assessment of active substances and other substances such as excipients, degradants and
  residual solvents

- Support with product information text in the context of the non-clinical assessment