Articles
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…
Articles
Most people would agree that it’s better to prevent a crisis than to have to deal with one. But the reality is, by their nature,…
Articles
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…
Case Studies
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…
Articles
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…
News
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…
Articles
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…
Articles
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…
Case Studies
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…
Articles
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…