Drug Project Toxicology

In addition to our long background in “big pharma” (at AstraZeneca), our consultants have several years of experience supporting small companies operating within the life-science sector. Our experts have had the opportunity to work with many pharmaceutical targets, and provide critical expertise to a large number of different projects. Our clients range from small academic biotech projects to large pharmaceutical companies. This guarantees a long and solid expertise in all areas where we offer our services. TKT offers several different cost-effective business solutions, all tailored to suit customer needs and resources.

Do not hesitate contacting TKT. We are happy to arrange a meeting / conference call, with the goal of identifying needs and finding out a suitable level of support. Below is a number of services and solutions TKT offer within the field of Drug Project Toxicology.

  • Full project responsibility, "one-stop-shop".
  • Risk assessment of drug targets.
  • De-risking of drug candidates in early discovery phases (non-GLP) by custom-made tox-strategies including design, timeline and evaluation of in vitro / in vivo studies.
  • Risk assessment and strategies for qualification of impurities.
  • Investigation of toxicological mechanism and relevance for humans.
  • Preparation and evaluation of preclinical safety packages to support various clinical development programs.
  • Assisting in the procurement of full preclinical study packages, or single studies, in vitro and in vivo studies
  • Planning, monitoring and reviewing general toxicology studies in drug development (GLP and non-GLP).
  • Authoring / quality assurance of the toxicology parts in regulatory documents, such as CTA, IMPD / IND, IB, AR / DSUR, BD, including integrated risk assessment of toxicology and safety pharmacology data according to current guidelines (ICH, EMA, FDA).
  • Interactions with authorities (FDA, MPA etc).
  • Toxicology support within Life Cycle Management.
  • In- and out-licensing / Due Diligence
  • Tailor-made literature and database searches according to customer needs.
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