The BIOSECURE Act did not arrive with ceremony. It arrived embedded in the National Defense Authorization Act, debated largely in abstractions, and passed with little public attention. But for pharmaceutical and biotechnology companies operating global […]

In a significant move to reshape its pharmaceutical landscape, China has unveiled a comprehensive guideline aimed at deepening the reform of drug and medical device regulation. Issued by the General Office of the State Council […]

The pharmaceutical landscape is evolving rapidly, and one of the most transformative shifts is the rise of direct-to-patient (D2P) distribution. As manufacturers seek to bypass traditional channels and deliver medications straight to patients’ doors, the […]

In the world of regulated industries—Quality Management Systems (QMS) are the backbone of consistent, safe, and effective operations. But here’s the catch: the language in ISO and other standards often leaves too much room for […]

Life sciences and healthcare organizations must have comprehensive risk management and crisis management plans that can provide for proactive risk scenario planning and a rapid response to supply chain emergencies. They also need to develop […]

Decision making might be tougher now than it has been for most of our careers. Today, we all have unprecedented needs for reliable info sources. “Grassroots” style info sharing is proving to be a critical […]