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.