In response to a landmark FDA warning, this analysis explores how regulators are shifting from automation to accountable stewardship, redefining governance expectations for AI across...

How evolving inspection expectations, digital manufacturing, and AI-enabled quality systems are reshaping pharmaceutical control strategies.  For many pharmaceutical organizations, the FDA’s draft guidance on  Considerations  for Complying with 21...

How digital regulation will reshape quality, compliance and operational expectations across the life sciences ecosystem. Written by: Cassidy Reid & Alice Redmond A Regulator Moving...

The 2023 revision of EU GMP Annex 1 reset the global standard for sterile manufacturing. It expands the guidance, tightens contamination-control expectations and aligns requirements...

As global regulations continue to evolve, life sciences companies are facing increasing pressure to meet stringent compliance requirements without slowing down innovation or compromising product...

The year 2024 has witnessed significant changes in the life sciences industry, characterized by seismic shifts in international regulations, a resurgence of national quality and...

This is the last installment of a three-article series that presents several lessons learned by our validation team while completing a pair of validation projects...

In a global community, studies are often conducted by testing facilities located outside of the United States of America, including countries such as Brazil, China,...

The US Food and Drug Administration (FDA) has launched a new Advanced Manufacturing Technologies (AMT) Designation program aimed at accelerating the implementation of technologies that...