Preclinical Services for Drug and Device Development
The Aptiv Solutions Preclinical development experts come armed with a wealth of experience and use this knowledge to guide clients along the optimal product development path.
Our preclinical services encompass all aspects of preclinical drug development and device development of small molecules and biologics such as proteins, antibodies, vaccines and oligonucelotides. These services include activities throughout the development of a compound or therapeutic agent as well as medical devices.
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
- Bioanalysis and immunogenicity
- Authoring of study reports
- Authoring nonclinical sections for all types of regulatory submissions such as INDs, CTAs, NDAs andMAAs
- Authoring nonclinical sections for all types of regulatory submissions such as IDEs, 510(k)s, and PMAs
- Review and consultation on preclinical issues affecting regulatory submissions
- Representation at regulatory agency meetings
Aptiv Solutions believes that intelligent preclinical design expedites development and maximizes clinical adaptability. 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 products that have progressed to clinical development with underlying or unresolved safety issues while others are dropped from development when these issues 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 drug development and device development group can help.