Chemistry, Manufacturing and Controls content
Navigating divergence: Practical lessons from the UK lifecycle management of licences
Four case studies demonstrate how marketing authorisation holders can optimise UK lifecycle strategy through the strategic use of national routes, the International Recognition Procedure and parallel submissions, despite increasing EU-UK regulatory divergence.
The drug development lifecycle: Regulatory milestones and pathways for early-career professionals
Aimed at aspiring or newly appointed regulatory professionals, this article outlines key stages of the drug development lifecycle and highlights the critical role regulators play throughout the process.
Beyond borders: Strengthening regional regulatory frameworks to end substandard and falsified medicines in Africa
This analysis examines the regulatory, economic and supply chain dynamics underpinning the issue of substandard and falsified medicines in Africa, and explores how regional harmonisation initiatives, emerging technologies and strengthened enforcement mechanisms can protect public health across the continent
Cell therapy, gene therapy and tissue-engineered product manufacturing: Technical challenges, enablers and regulatory evolution
This article examines the barriers that constrain cell and gene therapy accessibility, discusses emerging solutions and highlights current regulatory expectations
The evolving role of the regulatory professional in the age of Artificial Intelligence
This article explores how artificial intelligence can be used across dossier preparation, CMC, clinical development and more.
Empowering digital innovation in CMC: A framework for regulatory readiness and confidence
This article looks at the evolution of CMC and technologies, such as AI, to help with applications, regulatory assessments and more.
