Contact Us

IPM Insights

Articles

New Drug Commercialization

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…

Read More

Case Studies

Regulatory Expertise Eases the Way for Company’s First IND Submission

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…

Read More

Articles

Using CAPA to Comply with FSMA Can Improve Safety + Profits

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…

Read More

Articles

Prescription for Product Safety

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…

Read More

Case Studies

High Stakes Biotech – Pharma Alliance Successfully Launches Oncology Drug

A start-up biotechnology research company had made significant headway in the development of a drug to improve quality and length of life for patients with…

Read More

Case Studies

Harmonizing a Global Regulatory Submission Process Post-Merger

Project Background Following the merger of two major pharmaceutical companies, the newly formed (merged) organization quickly recognized that the processes for creating, managing, and archiving…

Read More

Case Studies

Complex global alliance successfully executes clinical trials

A pharmaceutical company formed an alliance with a global CRO to plan and execute multiple phase 1/phase II clinical trials for biosimilars to support development…

Read More

Case Studies

Reengineering of Work Processes Cuts Drug Development Timeline in Half

Project Background To be more competitive, a mid-sized pharmaceutical company needed to shorten its development timeline. To that end, it hired a globally recognized management…

Read More

Articles

No Time to Delay

Getting your Drug Approved is Half the Battle Abstract: How can pharmaceutical product managers react to the inevitable challenges that arise in the course of…

Read More

Articles

Compliance Issues? First, Don’t Panic

Abstract: Meeting compliance issues is like preparing for a hurricane: both situations require making sure that everything is nailed down well before the storm hits.…

Read More
1 2