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 classes (Wassergefährdungsklassen, WGK) |
Further to the services listed above, our experts provide customised concepts optimally fitted for your needs.
