Abstract
Recently, Scotia Pharmaceuticals submitted Epogam Capsules for registration through the multi-state procedure. A small company, at the time of the application, Scotia had 75 employees and a two-person regulatory department. This paper explores the decision process Scotia used to decide whether to go with a multi-state procedure, national procedures, or a combination of the two and the results of that choice, faster approval in two Member States and less drain on company resources.
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