CroToxPath can help you to develop a comprehensive nonclinical IND-enabling program for small molecules and biopharmaceutical drug entities.  We prepare nonclinical programs that are specifically tailored to your compound under development to meet local and global regulatory requirements. 

Our team will guide you through the lead drug optimization including assay development, and interpretation of findings to the regulatory and nonclinical requirements for the next phase of clinical development.

We will also identify cost-effective CRO’s (contract research organizations), who can provide nonclinical toxicology, pharmacology and genetic toxicity studies under GLP conditions.

We can write protocols for non-clinical studies, act as a Study Monitor, and review the study reports and help in interpretation of study results.

We also can do comprehensive literature searches and summarize the data relevant to the drug development program.

Finally we can prepare nonclinical parts of technical documents such as pre-IND’s, IND’s, CTAs, BLA, NDS’s, NDSs Briefing document, Investigator’s Brochures, etc.

We also can represent the client at regulatory agency meetings, and respond to any nonclinical issues raised by the agencies.

We can review your existing nonclinical program and advise you of any potential issues.  In cases where any potential issues will be out of the expertise of our team, we can identify other scientific experts, when needed, from our wide network of experts in Toxicology and Pathology fields.

CroToxPath can help you with the procedures involved in applying for a European, US and Canadian patent (through our associates), offering practical advice through the various stages of the application process. 

We can also help you in designing and placing target animal safety studies for veterinary pharmaceuticals.