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 […]
Four new entrants joined the EU-US Mutual Recognition Agreement for manufacturing sites for human medicines on March 1st. The four additional countries: Czech Republic, Romania, Greece and Hungary now join the eight existing members of the agreement.
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 […]
Our website is visited tens of thousands of times a year by professionals in the life sciences sector. Recently we took time out to analyse the stats and we have compiled a list of the Acorn Regulatory Top 100 most read articles ever on our website. You can see the full list and read all […]