MHRA’s Decentralised Manufacture Designation – Regulatory Framework
An overview of designation criteria, submission steps, and compliance considerations for POC and modular manufacturing
Inclusion of Pregnant and Breastfeeding Individuals in Clinical Trials : EMA Initiates Consultation on New Clinical Trial Guidance
The European Medicines Agency (EMA) invites public feedback on a new draft guideline focused on including pregnant and breastfeeding populations in clinical trials, addressing critical gaps in medicine safety and efficacy data. The consultation is open until 15 September 2025.
AI-Powered Pharmacovigilance: The Future of Drug Safety Surveillance
Artificial Intelligence (AI) refers to the simulation of human intelligence in machines, enabling them to perform tasks such as learning, reasoning, and problem-solving. In healthcare, AI has already shown significant promise in areas like diagnosis, treatment planning, and personalized medicine, transforming patient care delivery.
Overview of FDA Covered Product Authorization (CPA) and the CREATES Act
What is FDA Covered Product Authorization (CPA)?
FDA Covered Product Authorization refers to the official approval given by the U.S. Food and Drug Administration (FDA) for certain medical products to be marketed in the United States.
Health Canada Validation Criteria 5.3 – Compliance Update Effective May 31, 2025
As part of our continued commitment to regulatory compliance and operational excellence, we are notifying our clients, partners, and stakeholders about important updates to Health Canada’s Validation Criteria, version 5.3, which will come into effect on May 31, 2025.