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
Alliance Precision Plastics Cited for Lack of Written Procedures
The firm’s procedure for customer complaints did not gather enough detail to ensure they were processed in a uniform manner.
Judge Dismisses Drug Kickback Lawsuit Against Eli Lilly, Allows for Repleading
The judge found that the group’s claims were not strong enough, as it did not “set forth facts alleging an agreement to conspire.”
Clinical Trials
Site or sponsor? We have everything you need to know to make your trial a success.