Acorn Regulatory NewsBrexitIndustry NewsJanet FitzgeraldMarketing Authorisation HoldersPharmaceutical
Watch The Northern Ireland Protocol Webinar
Acorn Regulatory hosted a webinar in association with TOPRA on March 4th, 2021 to look at the issue of the Northern Ireland Protocol from a consultancy standpoint. The webinar was a fully booked event and generated significant interest among regulatory...
Acorn Regulatory Wins Best Service Provider 2019
Acorn Regulatory won the ‘Best Service Provider’ at the third County Tipperary Business Awards which were held at the Clonmel Park Hotel on Friday, October 18th.
DEKRA Chosen As 3rd Notified Body Under MDR
DEKRA, the German-based company, has been chosen by The European Commission as the third notified body to be accredited under the Medical Device Regulations (MDR). The new regulations come into effect on May 26th 2020.
2019 Pharma Awards Finalist – Acorn Regulatory Shortlisted
Acorn Regulatory has been shortlisted at the 2019 Pharma Awards in the Pharma Contract Services Company of the Year category. Founded in 2014, the Pharma Industry Awards recognises and celebrates the most original and innovative individuals and companies that demonstrate excellence...
Acorn Regulatory NewsIndustry NewsMarie CarrollMarketing Authorisation HoldersPharmaceuticalQuality Management SystemRegulatory Affairs
KASA – What You Need To Know About Knowledge-Aided Assessment and Structured Application
What is KASA and how will it impact on getting a drug assessed by the US FDA? We look at its ‘3 pillars’ and what it aims to be. Importantly, we look at how the FDA believes it will change...
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...
Acorn Regulatory NewsBrexitBrian ClearyComplianceEU Authorised RepresentativeIndustry NewsMedical DevicesPharmacovigilancePublicationsRegulatory Affairs
‘Selected Writing from Acorn Regulatory’ Download It Here
‘Selected Writing from Acorn Regulatory’ highlights just some of the most read articles written by our expert staff in the past 12 months. This e-book is packed with regulatory and pharmacovigilance insights from the team at Acorn Regulatory. Download it...
Acorn Regulatory NewsBrian ClearyChristine McGrathEU Authorised RepresentativeGemma RobinsonIndustry NewsPublications
Download ‘Regulatory Intelligence 5’ from Acorn Regulatory
We have published our latest e-book ‘Regulatory Intelligence 5’. This edition features a number of new articles from our expert staff. The articles look at a range of issues, many of the topics were suggested by clients or visitors to...
The US FDA DMF Deadline: 5 Things You Need To Know
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...
