Partum was asked to advice and support on aligning with the EMA on pivotal study design and choice of control arm by a clinical stage US based bio-pharmaceutical company. Partum initiated the due diligence efforts by presenting the precedents, the choice of their control-arm and relevant details that should be taken into account. Partum reviewed previous regulatory interactions and agency communications in conjunction with their experience on pivotal study designs accepted by EMA and presented risk assessment and gap analysis to the client. Partum advised and presented a rationale with pros and cons to seek a scientific advice with the EMA. We continued to support the client throughout the scientific advice briefing book drafting/submission, receiving final advice letter and MAA procedure.

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