Drug Project Toxicology
A skilled team of nonclinical safety experts providing integrated support from start to finish
- Expert toxicologists, CRO selection, study design and study monitoring, programme management and regulatory document authorising
- Multiple drug modalities, therapy areas and disciplines including genetic, reproductive, juvenile and investigative toxicology, safety, and secondary pharmacology and DMPK
Early consideration of potential safety liabilities from the drug target should form part of every discovery project. We will work with you to develop a balanced view of potential safety risks, directing you towards higher quality lead molecules and a greater chance of long term success.
Working alongside your team we will:
- Design and deliver a bespoke experimental strategy to address potential safety concerns
- Conduct focused target safety assessments to provide a succinct, risk-focused report that is directly aligned to your needs
- Explore potential in vitro and in vivo models that may enhance understanding of toxicities and their translation into the clinic
The regulatory GLP studies that underpin the clinical programme should be individually designed to address the scientific questions posed by the molecule, the indication and intended clinical use. Working in partnership with you, we will build a tailored, cost-effective non-clinical safety programme that enables the rapid execution of your clinical and regulatory development strategies.
Working seamlessly with your project team we will:
- Develop a nonclinical safety strategy that enables your clinical objectives
- Independently select the right CRO, develop study designs, manage study delivery, interpret data and review reports
- Prepare the nonclinical sections of regulatory submission documents including IMPD, IB, CTA, NDA/MAA/JNDA and expert reports
- Provide nonclinical support for regulatory agency meetings throughout the world including China and emerging markets
Promising compounds are bought, sold and partnered at all stages of the drug development process. Our experts have conducted many due diligence reviews and can give you the assurance you need to make a commercially sound decision.
Nonclinical Study Monitoring
It is essential that toxicology studies are designed appropriately, conducted to the highest standards and reported with clarity. An independent study monitor helps to select the right CRO and ensure delivery of a quality end product that meets the needs of the project.