The Latest Acorn Regulatory Newsletter
June 2020
This month’s edition of the newsletter features our latest drug-device whitepaper. You can download it below. This month we also look at the latest advice for MAH’s with regards to Covid-19.
Drug Device Whitepaper
The new MDR has significantly updated the requirements for medical devices placed on the European market. It has introduced new requirements for manufacturers to comply with to achieve CE marking before placing their products on the European market. The drug-device whitepaper provides an overview of the legislative changes, with a focus on the requirements for products that are typically known as drug-device combination products.
Expectations for Human Use Products During The Covid-19 Pandemic
The European Commission, the Coordination Group for Mutual recognition and Decentralised procedures – human (CMDh) and the European Medicines Agency have developed a ‘questions and answers’ document in light of the ongoing Covid-19 pandemic. The aim of the document is to provide guidance to Marketing Authorisation Holders on regulatory expectations and flexibility during the Covid-19 pandemic.
Essential Guide to Clinical & Medical Affairs
Our Medical & Clinical Services team works with companies all around the world and assists them with issues such as clinical trials, medical writing services, and medical information services. The Essential Guide to Clinical & Medical Affairs looks at the most read, downloaded and popular articles from the team in recent times.
Download our CMC E-Book
Acorn Regulatory’s team of CMC, pharmacovigilance, quality, clinical and medical devices experts consistently produce articles for the sector. In the CMC e-book, we have compiled some of the most-read articles into a downloadable PDF.
QMS & GDP/GMP Services
We understand that not every small to medium-sized company has the capacity to develop, implement, and maintain a Quality Management System (QMS).