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Marketing authorization application European regulatory agencies

In this context, it is also essential to build in regulatory compliance wherever possible. This is particularly important in markets such as the bio-pharmaceutical industry, where the auditability requirements of regulatory agencies such as the Food and Drug Administration (FDA) in the US or the European Medicines Authority (EMA) will need to be taken into account for many applications. Forward planning of this form can result in a market edge over more technology-focused competitors. [Pg.35]


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European Regulatory Agency

Marketing applications

Marketing authorization

Marketing authorization application

Regulatory agencies

Regulatory authorities

Regulatory authorities applications

Regulatory authorities marketing authorization

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