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To obtain a successful toxicology package, it is essential that preclinical studies are designed appropriately, conducted in accordance with the proper regulatory framework, and reported with clarity, within the required timelines and budget.
An independent study monitor helps with the selection of the right Contract Research Organization (CRO), and ensures delivery of a high quality product that meets the regulatory requirements. Not having this oversight can lead to study results that are not fit-for-purpose and consequently to delays, duplication of studies, and increased scrutiny by regulators; all of which can be expensive.
Planning, organization, as well as oversight and interpretation of outsourced in chemico, in vitro and in vivo toxicological studies according to GLP, OECD (chemicals), (V)ICH ((veterinary) pharmaceuticals), ISO (medical devices) and other guidelines:
We have extensive experience in establishing and monitoring in chemico, in vitro and in vivo toxicology studies for the following endpoints:
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