IPM Insights

There’s an adage that says what gets measured gets improved. Regulatory submissions are no exception. And with the growing complexity of clinical trials and increasing…

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…

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…

In March 2023, the European Commission got approval to extend the European Union Medical Device Regulation (EU MDR) deadline, which is a relief for patients…

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…

By Susan Carino, Principal Consultant, and Ruba Hadidi, Project Management Consultant Integrated Project Management Company, Inc. (IPM) No matter your company size or phase of…

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…

The implementation of the Food Safety Modernization Act of 2011 (FSMA) has forced food and beverage manufacturers to face some of the most sweeping safety…