IPM Insights

“Day One” is a key milestone in a merger or acquisition. The first day of legal ownership, Day One requires thorough planning to gain and…

What do successful mergers and acquisitions (M&A) integrations have in common? Timely and thorough planning. Companies often either wait too long to begin planning or…

By Carl Manthe, Director, Integrated Project Management Company, Inc. Most people would agree that it’s better to prevent a crisis than to have to deal…

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…

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…

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…

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 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…

A young biopharmaceutical company developing a pipe-line of preclinical cancer immunotherapy treatments was preparing to file its first investigational new drug (IND) application with the…