Your challenge – our solution

We provide scientific services to suit the needs of the pharmaceutical industry.
Our services include but are not limited to:

Non-clinical services

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


Environmental services

- Environmental risk assessments (Module 1.6.1), including
- PBT assessment (persistence, bioaccumulation and toxicity)
        - Tailored risk assessments for substances with specific classification, e.g. endocrine
           active substances
and antibiotics
        - Study planning and monitoring of all kind of studies required in the context of an
           environmental risk and/or PBT assessment (ecotoxicity, toxicology, fate and behaviour
           and physical chemistry)
- Support with product information text in the context of the environmental risk assessment
- Derivation of the Environmental Quality Standards (EQS) and the German water hazard
(Wassergefährdungsklassen, WGK)


Further to the services listed above, our experts provide customised concepts optimally fitted for your needs.