Embrace eBMR : 3 Key elements to Meeting Global Pharma Regulations – EU Annex 11; 21 CFR 11; Data Integrity – The core purpose of The Digital Imperative relating to eBMR application is to document every step of the manufacturing process
In the biopharmaceutical sector, MS&T responsibilities extend to both upstream and downstream processes. This includes optimizing cell culture conditions, managing bioreactor performance, and ensuring effective purification
The artificial intelligence revolution isn’t coming, it’s here. While only 13% of companies globally are ready to leverage AI and AI-powered technologies to their full potential, the organizations that prepare…
Pharmacovigilance, the science, and activities related to detecting, assessing, understanding, and preventing adverse effects or other drug-related problems, is critical in patient safety.
Health Canada has released a new Draft Good Manufacturing Practices (GMP) Guide for Natural Health Products (NHPs), marking a significant update in the regulation of supplements, herbal remedies, vitamins, and other natural health products in Canada. If you’re a manufacturer, distributor, or consumer of NHPs, this draft guide is worth paying attention to—it could shape