Aptiv Solutions Regulatory Strategy
Implementation of an appropriate regulatory strategy is critical to efficient drug development and the successful approval of products. Aptiv Solutions provide expert consultation for regulatory strategy development planning, agency advice and regulatory submission strategy.
In addition to strategic capability in the major markets, our regulatory team has practical experience in a wide range of procedures and products:
Regulatory Strategy Development Expertise:
- Clinical Trial and Marketing authorization applications in Europe, US and ROW
- Due diligence & data evaluations
- Orphan drug designations
- Pediatric investigational plans and pediatric development strategies
- Japanese regulatory strategy & advice
- Medical devices & drug-device combination products
- Small molecules & biologics
- Advanced therapy medicinal products
- Established drugs and generic products
