by Guest Blogger | Nov 12, 2021 | Guest Blog, Medical, Quality, Regulatory Affairs, Regulatory Intelligence
We welcome Sue Allen, Senior Regulatory Affairs Consultant, to discuss the practical considerations of international expansion and the questions that should be asked during the planning and execution stages of licencing your pharmaceutical products globally. As...
by Dr Lorraine Marsh | Sep 27, 2021 | Brexit, Regulatory Affairs, Regulatory Intelligence
Today we’re looking at renewals submitted for Marketing Authorisations (MAs) granted through the Centrally Authorised Procedure (CAP). For the basics on renewals please see my previous blog. A quick recap on how CAP licences will be handled – also see my...
by Sarah Neeson | Jul 26, 2021 | Regulatory Affairs, Regulatory Intelligence
Here we introduce a topic that can be seen as somewhat onerous, however it is vital for the compliance of both products and processes within the pharma industry. The Drug Information Association (DIA) defines Regulatory Intelligence (‘Reg Intel’) as; the act of...
