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.

Business cases

Case 1

Optimising international approvals

Case 2

Defining the regulatory class of a medical device