Preclinical Development
The Aptiv Solutions Preclinical development experts come armed with a wealth of experience and use this knowledge to guide clients along the optimal path through the development process.
We are experienced in all aspects of preclinical development of small molecules and biologics such as proteins, antibodies, vaccines and oligonucelotides. This experience includes activities throughout the development of compound or therapeutic agent including:
Preclinical Development Expertise:
- Lead optimization
- Development plans and study design
- Gap analysis, due diligence, trouble-shooting and data interpretation
- Vendor selection, study execution and study management for:
- Efficacy and safety pharmacology
- Toxicology
- ADME/PK
- Bioanalysis and immunogenicity
- Authoring nonclinical sections for all types of regulatory submissions such as INDs, CTAs, NDAs and MAAs
- Review and consultation on preclinical issues affecting regulatory submissions
- Representation at regulatory agency meetings
Our preclinical team can also tap into additional resources from our CMC, clinical and regulatory functions thus ensuring that your nonclinical program is not developed in isolation.
Aptiv Solutions believes that intelligent preclinical design expedites development and maximizes clinical flexibility. Our experts use their in-depth experience to design and implement cost-effective programs that have both speed and flexibility built-in. We often come across candidates that have progressed to clinical development with underlying or unresolved safety issues while others are dropped from development when these is-sues might have been resolved. We can help to resolve these issues,
Whether you are looking for consultancy and planning, supplier selection and management, authoring of the preclinical portion of a regulatory submission or simply study monitoring, the Aptiv Solutions expert preclinical development group can help.
