by Jessi O'Connell | Apr 30, 2026 | Insights
For years, many organizations approached accreditation with a familiar mindset. Build a solid set of standard operating procedures, document where key requirements are addressed, and ensure everything is organized well enough to pass review. That approach is no longer...
by Jessi O'Connell | Apr 23, 2026 | Insights
For many pharmaceutical and medical device companies, state licensing has historically been treated as a routine administrative function. Applications are submitted, renewals are tracked, and documentation is filed away until the next cycle. It has been a predictable...
by Jessi O'Connell | Apr 16, 2026 | Insights
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...
by Jessi O'Connell | Apr 14, 2026 | Insights
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...
by Jessi O'Connell | Apr 2, 2026 | Insights
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...
by Jessi O'Connell | Mar 30, 2026 | Insights
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...
