In support of your product and market development strategy, which regulatory strategy do you envisage to achieve the most effective goals?
At Nexialist, we always see an opportunity where others see a regulatory constraint. To maximise market access, we start with your strategic, business, financial and product objectives and we evaluate and define with you the various possible regulatory routes:
- Advantages and disadvantages of each option;
- Estimated time and cost of implementation;
- Planning of actions to conduct;
- Help in decision making at every stage.
Nex’strategy can be performed as support missions on a fee basis.
Optimising international approvals
Defining the regulatory class of a medical device