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    Tel: +39.02.72546330
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    • 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

    EMA Meetings
    EMA Submissions
    Regulatory Strategy
    Regulatory due diligence
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