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You should leave your meeting with EMA with understanding of critical questions and of the EMA’s expectations.
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Whoever is working on your project must ensure this happens.
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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.
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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:
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Scientific Adivice Meeting
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Protocol Assistance Meeting
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Orphan Drug Designation Meeting
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Pre-Submission Meeting (MAA)
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Meetings with Rapporteur and Co-rapporteur