REGULATORY

With years of experience to draw on, our extended network of regulatory experts have successfully managed the submission process for many dossiers in many countries.

Whether a simple, topical generic, with minimal clinical data (or even just Franz cell data), or a complex novel NCE, and everything in between including Orphan Drug and 505(b)2 submissions, Rune can advise, prepare and process your submission to a timely and successful authorisation.