Combination Products

The combination products industry is one of the most complex areas in healthcare, sitting at the intersection of pharmaceuticals, medical devices, and biologics. That overlap makes for an exciting but challenging regulatory landscape, especially as global requirements continue to evolve. In the US, companies must work closely with the FDA’s Office of Combination Products, juggling requirements from the agency’s drug, device, and biologics centers. Across the pond, the EU’s MDR and IVDR regulations demand a different approach, often requiring notified body involvement and CE-marking strategies. Then there are other regions, including Canada, Japan, and Australia, with their own unique expectations that can quickly turn a launch or approval process into a tangle of uncertainty.

When you partner with QualityHub, we’ll alleviate the pressure of various regulatory, quality, and compliance hurdles. Whether it’s sorting out primary mode of action questions, setting up robust quality systems, or aligning documentation to meet global submission standards, we bring real-world experience and practical solutions to the table. From early development to post-market compliance, we help you stay on top of shifting global regulations. With QualityHub, you don’t just keep up – you move forward with confidence.