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Case Studies

An Agile Approach Helps Optimize Digital Pathology System

The potential gains from digital pathology are endless. The ability to capture, curate, analyze, and rapidly share information about the effects of newly developed molecules…

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Articles

Parallel Global Submissions: Navigating the Space Between Submission and Approval

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…

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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…

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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…

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Case Studies

Careful Planning Critical to Successful M&A Integration

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…

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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…

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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…

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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…

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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…

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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…

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