The pharmaceutical and medical device sectors are facing unprecedented commercial pressures in every major healthcare market in the world. Issues such as increased competition, uncertainty regarding geopolitical issues such as Brexit and the individual nation’s drug pricing strategies have sent shock waves through the industry. Now, in order to survive and thrive there is a […]
Today is St. Patrick’s Day, the Irish national day of celebration, and we are highlighting just some of the multitude of Irish scientific innovations that have made a difference in our world.
The transition from paper based submissions to electronic Common Technical Document (eCTD) has continued in recent years. This is something that we have covered on this website on a number of occasions. The next deadline of note is that of the US Food & Drug Administration (FDA) Drug Master File or DMF deadline. That deadline […]
In this blog, John McIntyre looks at one of the most crucial choices Marketing Authorisation Holders must make when submitting a marketing authorisation application (MAA) – the choice of legal basis.
Sector specialists need to stay on top of developments in the sector. That is why we have produced another edition of our e-book series. ‘Regulatory Intelligence 2’ looks at a number of the critical issues in today’s regulatory sector.