Small US pharmaceutical company with its first EU Centralised MAA
Small US pharmaceutical company with its first EU Centralised MAA
1 Pageswww.ndareg.com/casestudies | October 2013 Get in touch | Paula Warmer, Head of Communications and Marketing | Paula.warmer@ndareg.com Page.1 The Challenge Pooling together a team comprising scientific advisors and regulatory consultants, NDA assisted the company in developing its PIP . We began by outlining the PIP strategy, considering all the paediatric needs and potential studies, through to preparing the application and taking the PIP
