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General Toxicology

Having supported more than 100 toxicology programs for over a decade: our expertise spans various therapeutic areas and all drug classes, including small molecules, biologics, oligonucleotides, and cell and gene therapies.

toxicology challenges

Common Challenges in Toxicology Programs

Because our team has been in the industry for so long, we understand that toxicology programs have many challenges. Some of the most common include the following:

  • The transition from Research to Development – a different mindset is required.
  • Program designs have to be customized to meet the expectations of the regulatory agencies and reflect the indication, drug properties, route of administration, and pharmacological activities.
  • Knowing where to start: Limited information on early discovery studies, in-vitro and in-vivo ADME, target engagement, and basis for species selection.
  • Program Oversight; many factors have to be considered – analytical and bioanalytical methods, API availability, CoA’s, animal welfare, and potentially activities across different sites.
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Our Approach To Supporting Your Toxicology Program

KreaMedica shares its enriched repertoire of experience and scientific knowledge to support your pre-clinical drug development program and ensure that it provides high-quality data to enable key decision-making.

We offer a tiered approach to supporting a Toxicology Program

  • Following a thorough gap analysis, our experts assist you in designing the studies with the program objective and need in focus.
  • We start with the end in mind: when and where do you wish to file?
  • We have the expertise, experience, and team to manage all program elements.
  • We have a network of seasoned industry veterans to address unforeseen events and findings where required.
  • Our scientific program managers monitor studies and identify key obstacles early.
  • We can support you before the North American and European regulatory agencies.
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