Biologics

The biologics industry is growing fast, but with that growth comes a complex web of regulations. The US FDA sets strict standards for everything from early development to post-market surveillance, while the EU brings its own layer of complexity with EMA guidelines and evolving requirements under the EU Clinical Trials Regulation and the Medical Device Regulation (MDR) for combination products. Meanwhile, other global markets add even more layers of requirements with unique expectations and time frames. Keeping up with shifting regulations across multiple countries and regions can feel overwhelming, especially for companies trying to stay focused on product innovation.

QualityHub partners with biologics companies to handle the regulatory, quality, and compliance pressures so they can keep moving forward with confidence. Whether it’s preparing for FDA facility inspections, managing EMA submissions, or staying compliant with global GMPs and GCPs, our team brings hands-on expertise and real-world solutions. From strategy through execution, we help ensure your company stays in compliance and is audit- and inspection-ready at every stage – without stalling progress.