Latest Articles

As AI capabilities scale, the FDA expects sponsors and their outsourcing partners to treat AI like any other regulated, computerized system that can influence safety, effectiveness, or quality–define the role, document credibility, control the lifecycle, and monitor performance. read more

In today’s hyper-competitive pharmaceutical landscape, innovation, speed-to-market and cost control usually take the spotlight when selecting a contract development and manufacturing organization (CDMO). However, underneath all those metrics, a single truth remains: if quality fails, so does everything else. read more