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...

This is the second in a series of three articles that present lessons that our validation team learned while completing a pair of validation projects...

After several years of conversation with drug manufacturers and consultants about the state of computer system validation, the FDA issued a draft of the Computer...

On January 26, 2024, the Food and Drug Administration (FDA) provided notification of a revised draft guidance on Remote Regulatory Assessments (RRAs).  The FDA has...

Drug shortages in the pharmaceutical industry is a significant concern that has far-reaching consequences for the industry, the regulators, the healthcare system, and ultimately the...