Confidence Beyond Compliance

Periodic and timely meetings with authorities have shown to increase the probability of a rapid market approval and can have a direct impact on development costs. But how do you get the best advice? Since authorities take the final decision to approve or reject products, it is highly recommended to optimize authority communication and to hold face to face and teleconference meetings all along the development timeline. Authorities encourage to start discussions as early in the development process as possible so that sponsors can become aware of concerns and be able to address issues before formal submission of a marketing application. Periodic and timely meetings have been shown to dramatically increase the probability of timely approval.

PharmaLex can help you in every step of the way, ensuring a highly professional interaction with authorities worldwide (including FDA in the US & EMA in Europe). Our staff have led hundreds of successful meetings with both the FDA and EMA and all major national agencies in Europe and worldwide. We are ready to help you achieve your meeting goals.