News and Events
Stay in touch with the latest news and upcoming events featuring Asphalion

CMC life-cycle maintenance in broad portfolios | 5 signs your approach may need to evolve
Managing CMC life-cycle activities across a broad product portfolio can become increasingly complex as regulatory demands grow. In this carousel, we highlight five signs that may indicate your CMC maintenance approach would benefit from a more structured, scalable, and strategic model. Discover how an optimized life-cycle management approach can help: Reduce the internal operational burden Improve consistency across regulatory documentation Strengthen regulatory responsiveness Support sustainable portfolio management as your organization grows Swipe through the carousel to explore the five signs and see whether it’s time to rethink your approach. At Asphalion, we support pharmaceutical and biotech companies in the
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Asphalion joins the ICEX Next Programme
We are pleased to announce that Asphalion has been selected as a beneficiary of the 2025.1 edition

VMD’s New Digital Service for Reporting Problems with VMPs
The Veterinary Medicines Directorate (VMD) has launched a new digital service for reporting adverse events associated with animal medicines, making it easier for veterinary professionals and animal owners to submit reports directly to the regulator.

EMA announces implementation timeline for Human eAF v1.28.0.0
Version 1.28.0.0 of the Human Marketing Authorisation Application (MAA) electronic Application Form (eAF) is now available. Industry

Pharmacovigilance Inspections | Pill 1
Are you prepared for your next Pharmacovigilance inspection? A successful PV inspection starts well before inspectors arrive.

Meeting the EMA milestone | Supporting successful PMS submissions
On 30 June, we reached a major regulatory milestone. At Asphalion, we supported some leading international pharmaceutical

FORUM INSTITUT COURSE | Variations in Europe
This practical seminar is aimed at anyone involved in planning, creating or submitting variations.
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