Articles – Video
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…
Case Studies
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…
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
Under new FSMA requirements, food and beverage companies are subject to FDA demands to quickly turn over data covering all aspects of a product—from ingredient…
Case Studies
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…
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…
Articles
Filling Dangerous Cracks in the Pharmaceutical Supply Chain By Reginaldo Montague, CFPIM, CSCPDownload PDF Prescription for Product Safety APICS magazine (September/October 2016) With 80 percent…
Case Studies
Big new legislative requirements mean big changes at even the most efficiently run companies. But when the company uses project leadership to incorporate those changes…