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Insights From Our Experts


The Data-Driven Revolution: AI’s Impact on Pharmaceutical Quality in Digital Therapy

In the intricate web of pharmaceuticals, a groundbreaking transformation is underway – one that marries data analytics with digital therapy, reshaping the industry’s landscape fundamentally. As the dust settles from the FDA Symposium, a seismic shift…

Unveiling the Future: AI Opportunities in FDA Compliance, Insights from the OPQ Symposium

In the dynamic realm of pharmaceuticals, staying ahead of the curve is not just an advantage; it’s a necessity. Recently, our team had the privilege of attending the CDER’s Office of Pharmaceutical Quality (OPQ) symposium, where…

Past and Present U.S. Public Health Laws and Regulations, and Their Impact on the Corresponding FDA Regulated Products and Industries

To be regulated by the FDA, foods, cosmetics, human and animal drugs, biologics, tissues, medical devices, combination products, and tobacco products have to meet the federal public health definitions. This white paper provides an overview of past…