You should leave your meeting with EMA with understanding of critical questions and of the EMA’s expectations.

Whoever is working on your project must ensure this happens.

To achieve your goals at a meeting with the EMA, the interaction must be carefully planned and executed flawlessly, leaving the EMA with a good impression of your product and company. This requires experts with prior regulatory experience who know the appropriate time to request a meeting, what is needed to prepare the necessary paperwork, what to expect when meeting with the EMA, and what steps should be taken post-meeting.

We should take your product and combines our knowledge of science, medicine  and regulations to prepare for each meeting. We will guide you step-by-step through EMA meetings during each phase of the development process including:

Scientific Adivice Meeting

Protocol Assistance Meeting

Orphan Drug Designation Meeting

Pre-Submission Meeting (MAA)

Meetings with Rapporteur and Co-rapporteur