Mastering CAPA Quality in the Era of QMSR
For decades, Corrective and Preventive Action (CAPA) has held a contentious position in the life sciences industry. Ask any Quality Director about their relationship with CAPA, and you will...
A Strategic Guide to Partnering with Integrated Delivery Networks (IDNs)
The pharmaceutical and biotech commercial model has undergone a seismic shift in the last two decades.
The traditional "share of voice" model, where success was largely determined by the...
How To Measure MSL Impact in the New Era of Biotech
For decades, the industry treated Medical Science Liaisons (MSLs) largely as a necessary ambiguity. They were the highly educated, scientifically credible field force who went where sales...
Post-Market Surveillance In Life Sciences
For decades, Post-Market Surveillance (PMS) has been the "eat your vegetables" portion of the life sciences lifecycle. It was necessary, mandated, and often begrudgingly executed by Quality...
Practical Non-Conformance Management In Life Sciences
A Non-Conformance Report (NCR) is the "check engine light" of your operation, a signal that something has deviated from the standard, requiring investigation and correction.
Executive Guide to Medical Device Compliance
For many startup founders and biotech executives, "compliance" conjures images of endless paperwork, fragmented spreadsheets, slowed innovation, and ballooning costs.
How To Build Effective Change Control in Life Sciences
It is a story as old as the life sciences industry itself.
Vendor Lifecycle Management: A Guide For Sponsors
In the modern life sciences ecosystem, the concept of the "vertically integrated" pharmaceutical company is largely a relic of the past.
Are You Ready For The QMSR Transition Deadline?
In the medical device industry, regulatory stability is the norm. The rules change slowly, often over decades. But every once in a while, a seismic shift occurs that forces every...
What Life Sciences Leaders Need To Know About ISO 9001
ISO 9001 gets a lot of airtime in quality circles, but for life sciences teams juggling FDA expectations, clinical milestones, and shifting regulatory frameworks, it can be hard to pin down...