The Road Map is a strategic regulatory analysis that evaluates regulatory requirements with the aim of proposing the optimal development strategy for your product, while integrating opportunities for interactions with relevant regulatory authorities throughout the whole development process.
The Road Map is delivered in an overarching master plan. It includes regulatory advice on potential non-clinical and clinical studies to support development, and recommendations on the fastest pathways to approval, including the pros, cons and risks of the alternatives, as well as a description of the timings of the regulatory applications.
How can DDR help?
- DDR will identify and propose the most successful way to address any regulatory requirements for securing the optimal development of your product.
- DDR will propose a tailored development strategy, including non-clinical and clinical aspects, according to the current available information on your product.
- DDR will investigate the opportunities for interactions with the relevant regulatory authorities.