US Food and Drug Administration Regulatory Pathways
Over the past five years, the medical device industry has witnessed an explosion of new and innovative...
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Data Integrity and Quality Culture
In this episode, host Erika Porcelli is joined by Susan Schniepp, Distinguished Fellow at Regulatory Compliance Associates...
Navigating Complexities of Name Changes and Re Registrations
Medical device manufacturers often overlook the complexities involved in changing product names or ownership, both of which...
Merger and Acquisition Re Registration: Navigating the Re Registration and other Complexities of M and A and Carve Outs
In M&A or carve-outs, pharmaceutical executives often underestimate the complexities of disentangling operations and the extensive effort...
The Metrics of Quality Culture
The long-awaited and anxiously anticipated FDA guidance on quality metrics was finally distributed for comment on July...