Have a look at the second video from our expert session, featuring Ana Viñas and Vicente Tur. In this discussion, they reflect on how the entry into force of the new European regulatory framework has transformed the regulatory landscape, highlighting the key changes and challenges, in the context of the Commission Delegated Regulation (EU) 2024 and the Commission Guidelines on the details of the various categories of variations.
At Asphalion, we have many years of proven experience in product Life-Cycle Management, supporting pharmaceutical and biotech companies of all sizes—from large multinationals to small and mid-sized enterprises. We take responsibility for the ongoing maintenance of products across various regional markets, including Spain, the European Union, and the United States. Our services include maintaining and updating technical dossiers and CMC (Chemistry, Manufacturing, and Controls) information to ensure regulatory compliance throughout the product’s life cycle. In addition, we assist with the review of promotional materials to support compliant marketing practices, helping our clients navigate complex regulatory landscapes with confidence and efficiency.
Have a look at the video here: https://youtu.be/_6VonsnHPGQ
Need assistance with your LCM activities? Contact us at: [email protected]
