Regulation of Pharmaceuticals in the EU

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 to your needs.