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
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
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 businesses.
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.
