Driving Innovation Through Changes to FDA Medical Device Regulations

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…

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…

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…

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…

Overseeing the development of a new medical device is a challenging undertaking. There are many moving parts involved in the process and risks and pitfalls…

A Project Leadership Perspective on Approaching Market Access A new drug product launch is an exciting time for a pharmaceutical company. New product development is…

A global multi-billion-dollar specialty pharmaceutical company was acquiring a smaller company with a pipeline of pain and spasticity drugs that would complement its own R&D…