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Correspondence with EMEA, FDA and/ or MHLW

Subsequent to the preparation and filing of the Orphan Drug application we also take care of the correspondence with EMEA or FDA or MHLW.

With adequate cooperation from your part an Orphan Drug application can be granted within a few months only.

Subsequent to granting the Orphan Drug Status we will advise you as far as the necessary steps for keeping this status are concerned.