Moving Beyond the Sandbox: How to Build Inspection-Ready AI in Regulated Life Sciences
For years, AI was just a tool for simple tasks like drafting emails. Those days of casual use are over. Regulators are tightening expectations, demanding strict AI governance, perfect traceability, and full integration with quality compliance systems. These rules are no longer optional best practices.
GLP and GCP: How the FDA and EPA Watch Over Science
Two of the most important sets of rules are called GLP and GCP. In 2026, the two main government agencies responsible for these rules, the Food and Drug Administration (FDA) and the Environmental Protection Agency (EPA), are working together more than ever before. Re: FDA & EPA Oversight.
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.
Matlock’s Misguided Take on the Opioid Crisis
The opioid crisis is a multifaceted public health crisis that has devastated communities around the world. This crisis is a result of a confluence of factors, including addiction, overprescribing, inadequate pain management education, and the illicit manufacturing and distribution of synthetic opioids. While opioids are a valuable tool for managing pain when used appropriately and under medical supervision, their misuse and abuse have led to widespread addiction, societal harm, and death by overdose.