Clinical & Non-Clinical / Toxicological Evaluations

Our clinical experts and non-clinical experts / toxicologists are specialised

  • in writing the Clinical Overview (Module 2.5) and Non-Clinical Overview (Module 2.4) as required for a marketing authorisation procedure
  • and evaluating specific critical questions which might be raised not only during a marketing authorisation procedure but throughout the lifecycle of a product, 
    e.g. assessing the genotoxic potential of impurities and developing strategies for distinguishing truly positive results which indicate a genotoxic potential from false-positive results.


Toxicological evaluations: Permitted Daily Exposure (PDE) calculation/determination strategies

According to the revised chapters 3 and 5 of the GMP guideline, the strategy for preventing cross-contaminations in shared GMP facilities should be based on a toxicological assessment of the products manufactured. The toxicological evaluation including the calculation of Permitted Daily Exposure (PDE) limits should have been completed by December 2015 for medicinal products for human use that are produced in shared facilities.


Our toxicologists and GMP experts are cooperating very closely 

  • in order to determine/calculate the Permitted Daily Exposure (PDE) for your active pharmaceutical ingredients (APIs) or critical excipients based on a pharmacological and toxicological evaluation in accordance with the revised GMP guideline and EMA’s "Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities".
  • and to develop adequate yet pragmatic solutions for your GMP environments, which reflect what is actually required from a toxicological and pharmaceutical perspective.


We help you evaluate, whether your current cleaning concepts are still adequate in view of the determined Permitted Daily Exposure (PDE) values or whether further action is required.


Our GMP experts have great experience in developing and implementing

  • containment solutions and cleaning concepts for highly potent APIs
  • and, of course, traditional concepts for APIs with moderate risk levels.