Regulatory Pathways FDA and EMA – Are You Prepared for Ongoing AI Supervision?
Regulatory pathways in the United States and Europe are becoming more complex. The FDA and the EMA continue to raise expectations for data quality, transparency, and oversight. At the same time, regulators are expanding their use of advanced digital tools, including artificial intelligence, to review submissions, monitor compliance, and identify risk.
Why the US Leaving the World Health Organization is Short-Sighted
On 22 January 2026, the United States announced that it was formally withdrawing from the World Health Organization. Public health experts, analysts, scientists, and those of us who work in the field find this a dangerous decision that will jeopardize national and global security and is scientifically reckless.
The Rise of Patient-Centric Packaging in Pharmaceuticals
In recent years, the pharmaceutical industry has begun to rethink its approach to drug packaging. No longer is packaging only a protective shell for medicines. Today, it is evolving into something much more meaningful: a bridge between drug makers and patients. This shift is called patient-centric packaging. In this post, we will explore what patient-centric packaging is, why it matters, and how it is transforming the way medicines are delivered and used.
Understanding the Significance of CRLs Being Released: Beyond the Regulatory Language
The FDA's Complete Response Letter (CRL)-- few documents hold as much weight in the complex and often opaque world of pharmaceutical development, as the CRL. Metis Consulting can help navigate them, learn more at our blog, The Guard Rail.
