In life sciences manufacturing, inspections by the FDA, state regulators or other agencies are part of the job. But too often ...

DUBLIN--(BUSINESS WIRE)--The "Data Integrity and Document Management Training Course" conference has been added to ResearchAndMarkets.com's offering. Document management and data integrity are a key ...

After a quiet January marked by administrative transition and internal upheaval at FDA, enforcement activity has accelerated sharply in 2025. No warning letters were issued in the first month of the ...

Following Viatris’ December announcement that a manufacturing plant in India had been written up by the FDA, a document published by the U.S. regulator reveals the details behind the company's ...

Chris is the CTO and Co-Founder of Scientist.com, a Research Platform helping drug discovery researchers develop new therapies. The FDA’s adoption of electronic submissions raised concerns about data ...

WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) has issued General Correspondence Letters to two third-party testing companies in China after uncovering falsified or otherwise invalid ...

Audit preparedness is essential for every clinical research site. By operationalizing compliance in your daily procedures, you can effectively mitigate risk and ensure smooth inspections. Start by ...

Opportunities lie in enhancing data integrity auditing skills within pharmaceutical manufacturing, focusing on GxP audits. Companies can capitalize by offering comprehensive training that delves into ...

PHILADELPHIA, Nov. 25, 2025 /PRNewswire/ -- Rx-360, the International Pharmaceutical Supply Chain Consortium, is proud to announce a strategic partnership with Leucine, an AI-powered platform ...

Zydus Lifesciences Limited has informed stock exchanges that the United States Food and Drug Administration (USFDA) has ...