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 […]
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.
As regulations and guidelines become broader, more electronic and increasingly data driven, manufacturers must adapt with ever changing demands. Regulators are shifting more responsibility onto manufacturers to instil quality throughout their operations and throughout their product lifecycles. In the past, small and emerging life sciences companies might have functioned sufficiently with manual processes and disconnected systems, but may […]
For many companies bringing a product to market, the biggest issue to contend with is the matter of finalising the regulatory procedure. However, for small and medium life science companies that might not have a presence in a particular market, this is not the biggest issue. The matter of completing national phases in each country […]