News and Events
Stay in touch with the latest news and upcoming events featuring Asphalion
NEWS | New revised ICHM4Q guide
On May 14th, the International Council for Harmonisation (ICH) published the revised ICH M4Q guide. This guide plays a crucial role in outlining the structure of Chemistry, Manufacturing, and Controls (CMC) information for Modules 2 and 3 of the Common Technical Document (CTD), making it highly relevant for all pharmaceutical submissions. The revised ICH M4Q guide establishes the groundwork for electronic data standards that facilitate structured applications. It aligns with other ICH guidelines (such as ICH Q8 to Q14) and promotes the adoption of risk-based approaches, including Quality Target Product Profile (QTPP), Technical Risk Assessment (TRA), and Product Control Strategy
More News & Events
HORIZON EUROPE | GreenNanoBone KoM
This European-funded project aims to develop a treatment for medication-related osteonecrosis of the jaw (MRONJ) using sustainable, biocompatible, bioactive, and antimicrobial 4D materials derived from food waste.
Regulatory requirements | Overview and updates
As many of you know, we’re in the midst of a wave of important regulatory updates. To
DIGITALIZATION | FDA on the use of AI
At Asphalion, we are strongly committed to driving digitalization and integrating innovative tools to enhance our work.
HORIZON EUROPE | PreKoM GreenNanoBone
Yesterday, we celebrated the Pre-Kick off Meeting for the new GreenNanoBone project at our Barcelona offices. Alongside
Awareness Workshop on Equal Opportunities: Diversity and Inclusion
This afternoon we had the pleasure of participating in an awareness workshop on equal opportunities, diversity, and
HORIZON EUROPE | Third meeting Methylomic project
This remarkable initiative is set to redefine personalized treatment for Crohn’s disease (CD) through cutting-edge innovations in in vitro diagnostic medical device software.
Search or filter
