Compliance Issues? First, Don’t Panic

This article was originally published on MasterControl’s GxP Lifeline blog as How to Avoid—but Prepare for—Compliance Crises. What happens when a medical technology company gets…

Read the article below or download the complete PDF: "Don't Let a Crisis Become a Disaster" → When you hear “crisis,” you think “COVID.” But a…

The good news is that the FDA is enhancing review processes to ensure medical devices are safer and more effective. But are your new products…

Integrated Project Management Company, Inc. (IPM) is proud to announce that seven of its pharmaceutical, medical device, and biotech regulatory experts will share their knowledge…

Development of a novel therapeutic takes several years of intense research and detailed planning. Because target populations are likely to be distributed over multiple regions…

It’s challenging for a consumer products company to launch a product line into a new global market. It’s even more difficult to enter several new…

This article has been updated to indicate that the European Union Medical Device Regulation deadline has been extended one year, until May 26, 2021.  According…

Integrated Project Management Company, Inc. (IPM) has expanded its Centers of Excellence (CoEs) to help organizations address specific business challenges and successfully execute on their…

If you are confused by the many acronyms related to regulatory submissions, you are not alone. A variety of data from disparate functions must come…