At Asphalion, we’re dedicating this week to highlighting the importance of Life-Cycle Management (LCM), a key part of maintaining regulatory compliance, optimizing submission processes, and supporting product evolution throughout its time on the market.
We’re starting today with information about the electronic Application Form (eAF), a critical tool for efficient regulatory maintenance.
The Electronic Application Form (eAF) is a unified EU form used for human and veterinary MAAs, variations, and renewals. It combines PDF for input and XML for data transfer, enabling data import/export, auto-copy, self-validation, and access to standardized term catalogues (EUTCT)—streamlining regulatory submissions and reducing manual input.
Join us in celebrating LCM-Week! Stay tuned for insights throughout the whole week!
Need assistance with your LCM activities? Contact us at: [email protected]
Have a look at our infographic here: Get ready for eAF
