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, our expert webinar tomorrow, and more materials.
Need assistance with your LCM activities? Contact us at: [email protected]
Have a look at our infographic here: LCM week – eAF.pptx
