Posts Tagged ‘RAPS’

Navigating the Complex Landscape of Combination Product Regulations

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 Turns 20!

Celebrating 20 Years of Excellence and Innovation!

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 October 2004, QSN has seen tremendous growth, now serving a diverse range of clients in the medical device, drug, and biologic manufacturing sectors.

As we celebrate our 20th anniversary, we reflect on our journey and the remarkable milestones we’ve achieved. Here’s a look at our progress:  Read more »