CMC Guidelines & More – #ICYMI from the Acorn Regulatory Archive
Each month we feature some of the excellent articles written by our expert staff that you might have missed. In this month’s edition of In Case You Missed It (#ICYMI) we look at the update to CMC guidelines, we impart...
Impacted By The LRQA Decision? Here Is How We Can Help
The decisions by Lloyd’s Register Quality Assurance (the LRQA) and QS Zurich that they will both will cease to offer notified body services under the EU’s existing medical device and in vitro diagnostic directives and that they will not seek...
Get The Acorn Regulatory Medical Device Regulations Whitepaper
The new medical device regulations (MDR) will come into force in May 2020. In advance of the deadline, companies across the world are working to ensure that their devices will comply with the new regulations. For many companies there is...
Acorn Regulatory Managing Director Speaks At National Manufacturing Conference
Dr. Gemma Robinson, Managing Director of Acorn Regulatory was among the speakers at the 2019 National Manufacturing Conference held on January 17th at the Citywest Hotel in Dublin. Dr. Robinson was speaking on the topic ‘Brexit: Current Agreements & Implications for...
EU – US Mutual Recognition of Inspections Enters Operational Phase
The EU – US mutual recognition of inspections entered into its operational phase earlier this month when eight countries became the first territories outside of the USA to have their inspectorates recognised by the FDA.
Acorn Regulatory News Roundup December 2016
In Acorn Regulatory News for December 2016 we are looking back at five of the stories over the past month that have caught your attention on our website and through our social media channels.
Industry News Roundup: November
This month in our news roundup we are looking at Wholesale Distribution Authorisation (WDA), President-Elect Trump, awards and more.
Industry News Roundup: October
In between constantly managing regulatory affairs submissions for our clients and dealing with some of the most dynamic healthcare companies around the world, our team has picked 5 of the top stories from the last thirty days.
Get The Industry News Roundup for September
In this month’s roundup of industry news roundup, we will be looking at how the USA and Canada are working to align their submission gateways to assist companies making regulatory applications. We will also look at a new EMA drug...
