News and Events
Stay in touch with the latest news and upcoming events featuring Asphalion
WEBINAR | Biological Impurities: Scientific and Regulatory Aspects
Join us for an in-depth session abput “Biological Impurities: Scientific and Regulatory Aspects”, where our Regulatory Affairs expert Mario López de la Cruz will guide you through the scientific complexities and evolving regulatory landscape surrounding biological products. This webinar offers a practical overview of how impurities in biological medicines are identified, evaluated, and controlled under both European and U.S. regulatory frameworks. Whether you’re in R&D, regulatory affairs, or quality assurance, this session is designed to help you confidently navigate the complex challenges of biologics. The webinar will cover: Definitions and particularities of biological products according to EU and US regulations
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WORLD THALASSAEMIA DAY | RAISING AWARENESS
Today marks International Thalassaemia Day, a global initiative to raise awareness about this rare genetic blood disorder.
EVENT | MedTech Forum 2025
ASPHALION is excited to announce our participation in the MedTech Forum 2025, one of the leading events
NEWS | CHMP Adopts Draft ICH Q1 Guideline on Stability Testing
On April 24, 2025, the Committee for Medicinal Products for Human Use (CHMP) adopted the draft ICH
Optimize your Environmental Risk Assessment (ERA) during the MAA procedure
Ensure compliance. Promote sustainability. Minimize regulatory hurdles.
Asphalion Medical Writing Services | Supporting Your Regulatory Success
Clear, accurate, and regulatory-compliant documentation is essential at every stage of pharmaceutical and biotech product development. At
ARDAT | General Assembly Meeting in Barcelona
Last week, ARDAT project members gathered in Barcelona for the project’s General Assembly. The ARDAT project is
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