Compliance Issues? First, Don’t Panic

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…

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 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…

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…

When a global pharmaceutical and medical device company acquired another organization’s product portfolio, it faced the daunting task of integrating the new products into its…

The R&D team of a global medical device company was experiencing project slippage, diluted resources, prioritization problems, and too many projects within its current portfolio.…

When it comes to launching a new product, even companies with the most meticulously planned schedules can find themselves missing milestones while waiting—and waiting—for approval…