Regulatory Support Services

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Integrated or dedicated consultancy for your team in all aspects of interactions with Health Authorities (HAs) wherever in the world including:

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Responding to complex statistical questions from HAs
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Representing or rehearsing your company for meetings with HAs, including Advisory Committees

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Helping your team create their clinical submission for (s)NDA or MAA

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Deciding what further analyses are required to understand your data

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