Toxicological assessment in the drug development (small molecules and biologics)
A selection of our services:
- Risk assessment of drug targets.
- Risk mitigation of drug candidates in early phases.
- 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 in production and final formulations.
- Problem solving (Molecular toxicology / Bioinformatics / Mechanistic investigations).
- Preparation and evaluation of preclinical safety packages to support various clinical development programs, including integrated risk assessment of toxicology and safety pharmacology data according to current guidelines (ICH, EMA, FDA).
- 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.
- Interactions with authorities (FDA, MPA etc).
- Toxicology support within Life Cycle Management.
- In- and outlicensing / Due Diligence
- Tailor-made literature and database searches according to customer needs.