Resources

Why Cybersecurity Has Become a Regulatory Priority As combination products increasingly rely on software, connectivity, and digital interfaces, cybersecurity has moved from a secondary concern to a core regulatory expectation....

Why Design Controls Are the Biggest Leap for Drug Teams For pharmaceutical and biologic organizations entering the combination product space, few regulatory requirements cause as much friction as design controls...

In this episode of the Ask the Expert video series hosted by Pharmaceutical Technology®, Susan J. Schniepp, Nelson Labs, and Siegfried Schmitt, Parexel, discuss the benefits of orphan drug development...

Pharmaceutical and biologics companies are rapidly moving into prefilled syringes, autoinjectors, on body injectors, and connected delivery systems, but most discover too late that their traditional drug based QMS cannot...

Background A pharmaceutical manufacturer faced a significant capacity shortfall for a high-value drug product, with demand forecasts projecting accelerated growth. The expansion carried a high-risk profile due to complex interdependencies...

The FDA’s Quality Management System Regulation (QMSR) replaces the legacy QSR and formally incorporates ISO 13485:2016 (and ISO 9000:2015 Clause 3 for terminology) by reference. The final rule was issued...