Obviously not even the most efficient company will be able to get simultaneous registration in all the major territories it operates in. However, if well managed and with effective planning it could reasonably expect to get registration in, say, ten territories within a short timescale. Different drug-regulatory authorities have disparate concerns and therefore questions on the submitted dossiers will naturally be different. It will be largely impossible to anticipate the majority of these no matter how perspicacious are the company’s regulatory-affairs personnel.
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