Home > Regulatory Affairs > Prime Eligibility Request

This initiative by the EMA aims to enhance support for development of medicines that target an unmet medical need.

Our consultants are familiar with both the challenges and best practices in submitting your PRIME Eligibility Request to the authorities as soon as you finish the relevant stage of development. By providing you with preparation support early on, you can generate the robust data on your drug product’s benefit/risks ratio, required for accelerated assessment by the EMA.

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with our Xpert

Elise Destrée

Managing Consultant, Regulatory Affairs

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