News
EMA’s new work plan: Leveraging data and AI to encourage innovation and research
20 May 2025
The European Medicines Agency (EMA) published a workplan on its ambition to leverage high volumes of data and artificial intelligence (AI).
Representative experience
Despite client’s 2 non-approvable letters before our work, we helped with PMA amendments & secured unanimous Advisory Panel approval recommendation.
Ran PMA & Advisory Panel process & gained approval for novel, non-invasive screening test using advanced DNA technology detecting colorectal cancer.
Managed PMA & Advisory Panel Process & facilitated approval for novel tissue glue product that removes need for abdominoplasty post-surgical drains.
