October 27, 2025
2025 is shaping up to be another highly active year for the FDA enforcement of Current Good Manufacturing Practices (cGMPs). As I have been reviewing 2025 warning letters, one thing is clear: the same themes keep surfacing across different companies, product types, and geographies when it comes to FDA Enforcement. What strikes me is that […]
October 20, 2025
In September 2025, the U.S. Food and Drug Administration (FDA) issued a new guideline titled “Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications”. Purpose and Scope This article outlines how the FDA intends to leverage innovative approaches—beyond traditional on-site inspections—to evaluate the readiness and compliance of facilities named in new drug applications (NDAs), abbreviated […]
October 13, 2025
A Summary of Quality-Driven Growth as the New Strategy for Life Sciences Leaders In the highly regulated world of life sciences, encompassing biopharmaceuticals, medical technology (MedTech), and Pharmaceuticals, quality has long been synonymous with compliance. Adhering to frameworks such as FDA 21 CFR Parts 210, 211, and 820 (for medical devices), ICH Q8–Q12, FDA 21 […]
October 6, 2025
Everyone says they don’t want a quality function that serves as “the cops.” A group that only focuses on audits, metrics, and compliance. Please make no mistake, that enforcement is part of the job, and while those are critical functions, merely performing those tasks exclusively will never take your quality organization to where it needs […]
September 8, 2025
In highly regulated industries such as pharmaceuticals, biotechnology, and medical devices, quality and risk management are not optional; they are the foundation of regulatory compliance, product safety, and patient trust. Risk management is a strategic discipline that focuses on proactively identifying potential hazards associated with medical devices, pharmaceuticals, and biotechnology products. It evaluates the severity […]
September 1, 2025
As the MedTech industry embraces Artificial Intelligence (AI)- driven diagnostics, robotic-assisted procedures, patient-centric healthcare solutions, and smart implants, the promise of meeting unmet patient needs and enhancing clinical outcomes grows exponentially. The industry has positioned itself as the advocate for patients, promoting an improved quality of life. Yet, with innovation comes complexity—and the challenge of […]
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