News

  The message is no longer subtle. It is not a warning shot. It is enforcement. A recent action involving U.S. Food and Drug Administration and Pure Indulgence Aesthetics has fundamentally changed the tone around the Drug Supply Chain Security Act. What was once...

  There’s no question that technology is reshaping the pharmaceutical industry. From advanced analytics to AI-driven automation, the promise is compelling: faster workflows, lower costs, and fewer manual errors. In licensing and regulatory compliance, that...

If you manage licensing and pharmaceutical compliance for a life sciences or medical device firm, you know the "Sunday Scaries" of the industry: a patchwork of spreadsheets, creeping renewal deadlines, and the constant, low-grade fever of evolving DSCSA requirements....

For Contract Manufacturing Organizations (CMOs) and Contract Drug Manufacturing Organizations (CDMOs), licensing has traditionally been viewed as a requirement tied to physical operations. If you manufacture, repackage, or distribute from a specific state, you...

The FDA recently finalized a rule that will reshape one of the most widely used identifiers in the pharmaceutical industry: the National Drug Code (NDC). Through its final rule, “Revising the National Drug Code Format and Drug Label Barcode Requirements,” the agency...

Strengthen DSCSA compliance with effective trading partner verification. Learn why continuous license monitoring, audit-ready documentation, and proactive processes are critical to avoiding risk and ensuring regulatory compliance.

State licensing requirements continue to evolve across the pharmaceutical and medical device landscape. New rules, updated interpretations, revised application forms, and changing renewal timelines can all affect a company’s ability to operate compliantly. For...

For pharmaceutical manufacturers, wholesale distributors, 3PLs, repackagers, reverse distributors, and medical device companies, state license renewals are often viewed as routine paperwork. A deadline to track. A form to submit. A fee to pay. But in reality, state...

Drug price transparency reporting remains one of the most challenging compliance obligations for pharmaceutical companies. While these requirements have been in place for several years, state legislatures and regulatory agencies continue to refine their expectations,...