Nonclinical Safety Testing Guide

Early drug discovery and development present numerous challenges, requiring strategic planning and execution to advance the most promising candidate toward regulatory approval. A comprehensive evaluation of efficacy and toxicity is essential before progressing to human trials. This document provides an overview of the preclinical phase of drug development, highlighting the importance of early preparation and collaboration.

To ensure a smooth process, engage with a contract research organization (CRO) like Altasciences at least nine to twelve months in advance. This allows ample time to address critical factors such as resource availability, capacity planning, and securing animal supply, while also establishing realistic timelines. Equally vital is initiating discussions with the regulatory agency in the country where you intend to submit your IND or CTA. These consultations, in partnership with Altasciences, help tailor a development strategy that addresses your specific needs. By planning proactively and collaborating effectively, you can optimize your chances of success and streamline the path to regulatory approval.