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Scientific Advice

Our team can provide the necessary support to our clients with the right level of scientific advice on the most appropriate way to generate robust evidence on a medicine's benefits and risks, either on a national or EMA level. This could be which EU national competent authorities are most capable of advising on your particular product to resolving conflicting advice from different EU authorities.

Whether that is wondering when do you request Scientific Advice on your development programme and what questions do you ask, how does the Scientific Advice process work within different Authorities or how do you follow up on the advice, Assion can provide the answers.

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Old molecule for a new indication an Assion case study

A US start-up business, specialising in the field of gastroenterology, was looking to repurpose an old molecule for a new indication encompassing a different route of administration.