Posts Tagged ‘regulatory’
Navigating Regulatory and Patent Challenges in the Combination Products Space
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 and patent protections often demands significant expertise and foresight from industry stakeholders. Read more »
Elisa Kim, Mike Wallenstein, John “Barr” Weiner and Khaudeja Bano spoke at the Combination Products Summit. Source: Michele G. Sullivan
Insights From Combination Products Summit
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 different countries have their own definitions and requirements for these products. This lack of uniformity complicates the application process, adding layers of complexity and burdening manufacturers. Read more »
Quality Solutions Now and ComplyFDA Partnership
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 collaboration enhances our capabilities in providing comprehensive, scalable, and cost-effective solutions, ensuring clients meet and exceed quality and regulatory standards. Read more »
