Simplifying Global Compliance
Recommended Products
GMP Inspection Preparation Checklist: A Tool for Internal Auditing
This management report includes more than 650 items organized in three sections covering all aspects of quality manufacturing.
Biological Risk Evaluation and Management for Medical Devices
Report shows how the FDA incorporates the two ISO standards in its medical device development policy, how the EU version of the two standards differs in significant ways and how the EU Medical Device Regulation may require further changes in the European standards.
Editor's Picks
Heidelberg’s Angiography Module Approved
Physician can map and measure the thickness of the retina’s layers.
Sponsors Who Don’t Report Trial Data Could Be Hit With Fines, FDA Says
The agency will prioritize cases where sponsors have failed to submit trial registration or results for higher-risk trials.