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 [...]
The journey of developing and commercializing combination drug/device products is filled with challenges, primarily due to the non-harmonized global regulatory frameworks. As discussed at the recent 2023 Combination Products Summit, manufacturers face significant hurdles because [...]
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 [...]
Leading the Way in Life Sciences Compliance and Quality Management Quality Solutions Now (QSN) and ComplyFDA have joined forces to offer unparalleled solutions in quality management and regulatory compliance for the life sciences industry. This [...]