The FDA plays a critical role in regulating medical devices, pharmaceuticals, and biologics, ensuring the safety and efficacy of healthcare products. However, with recent political shifts, leadership changes, and funding concerns, the regulatory landscape is [...]

The combination products sector is an exciting intersection of drugs, devices, and biologics, offering immense potential to revolutionize healthcare. However, with this potential comes a uniquely challenging regulatory environment. The complex landscape of global regulations [...]

Outsourcing, partnering, or hiring specialty expertise consultants—regardless of the term used, this practice is becoming increasingly prevalent in the healthcare industry. Faced with budget cuts, downsizing, and layoffs, manufacturers of drugs, medical devices, biologics, and [...]

The healthcare landscape is constantly evolving, and with it, the need for innovative solutions in combination products—those unique blends of drugs, devices, and biologics that present distinct challenges for development and commercialization. The 2024 Combination [...]

Recently, Michael Kuehne at ComplyFDA conducted a deep dive into developing a baseline assessment using a risk-based approach looking at all quality processes. This approach delivers actionable improvement recommendations and incorporates validated best practices to [...]

Twenty years ago, Quality Solutions Now (QSN) embarked on a mission to create a world where health is protected and promoted through the manufacturing of safe and effective medical products. From our humble beginnings in [...]