Pharmacovigilance, the science, and activities related to detecting, assessing, understanding, and preventing adverse effects or other drug-related problems, is critical in patient safety.
The U.S. Food and Drug Administration (FDA) has recently updated the required warning information in the labeling for mRNA COVID-19 vaccines manufactured by Moderna and Pfizer-BioNTech.
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
The biopharmaceutical industry operates within a complex web of regulatory requirements, demanding meticulous attention to quality and compliance at every stage of a project. From early-stage research to commercial manufacturing, deviations can have significant consequences, impacting patient safety, product efficacy, and the company’s reputation. Optimizing quality and compliance is not merely about ticking boxes; it’s a strategic imperative that drives efficiency, reduces risks, and fosters innovation.
In today’s rapidly evolving biotechnology landscape, regulatory challenges often determine the difference between groundbreaking innovations that reach patients and those that remain trapped in development limbo. We’re excited to announce the release of our comprehensive white paper, “Navigating the Regulatory Landscape: 10 Critical Challenges for Biotech Companies,” designed to help innovators chart a successful course