Complying with Canadian Food Safety and Labeling Standards: A Regulatory Overview For businesses involved in the marketing or distribution of food in Canada, businesses must comply with the regulatory framework set by Health Canada and the Canadian Food Inspection Agency (CFIA). These regulations ensure that food sold in Canada is safe, properly labeled, and nutritionally… Continue reading Complying with Canadian Food Safety and Labeling Standards: A Regulatory Overview
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MHRA’s Decentralised Manufacture Designation – Regulatory Framework
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
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… Continue reading Inclusion of Pregnant and Breastfeeding Individuals in Clinical Trials : EMA Initiates Consultation on New Clinical Trial Guidance
AI-Powered Pharmacovigilance: The Future of Drug Safety Surveillance
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
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
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.
Swissmedic Nitrosamine Risk Assessment Requirements
Swissmedic Nitrosamine Risk Assessment Requirements Swiss agency updated the guidance on nitrosamines in active substances and/or finished medicinal products in the corresponding specification documents.
Scheduled Maintenance Notice: ESG NextGen Platform Downtime on May 17, 2025
Scheduled Maintenance Notice: ESG NextGen Platform Downtime on May 17, 2025
The Role of Artificial Intelligence Within the Pharmaceutical Sector
The Role of Artificial Intelligence Within the Pharmaceutical Sector: Businesses in a fast-changing world have always taken advantage of the market’s opportunity to improve their processes, making them smarter, more effective. With the help of Al and machine learning, companies are able to reach their peak efficiency in data analysis that will leave an enormous impact on each other’s… Continue reading The Role of Artificial Intelligence Within the Pharmaceutical Sector
Navigating EMA’s Updated Paediatric Application Procedures: April 2025 Insights
Navigating EMA’s Updated Paediatric Application Procedures: April 2025 Insights On 15 April 2025, the European Medicines Agency (EMA) released an updated version (Rev. 121) of its procedural advice on paediatric applications (EMA/672643/2017). This revision reflects the agency’s commitment to streamlining regulatory processes, enhancing transparency, and supporting innovation in paediatric medicine development across the EU.