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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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Transform Your Strategy Execution to Transform Your Organization

Depending on the research cited, 60 to 90 percent of businesses fail to execute their strategies. This is often due to the executive team’s lack…

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4 Steps to Hit Your Product Launch Target

Whether it’s to beat the competition, gain credibility or buzz with a new product, or just start reaping new revenue ASAP, launching new products quickly…

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Steps to Accelerate Successful EU MDR Compliance

Medical device manufacturers have just over six months to be compliant with the new European Union Medical Device Regulation (EU MDR). Yet according to a…

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Three imperatives to turn an enterprise software implementation into a digital transformation

Enterprise software is a tool, not a silver bullet. While the implementation of enterprise-level technology such as enterprise resource planning (ERP) and customer relationship management…

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Alphabet Soup: HOW GXPS IMPACT THE QUALITY OF A REGULATORY SUBMISSION

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…

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A Strategy Execution Roadmap for Navigating the Baldrige Journey

Integrated Project Management Company applied its Strategy Realization Model for transforming organizations to prioritize and execute its Baldrige pursuit—and used Baldrige feedback to improve the…

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Strategic Realization Helps Win the War for Business Success

Business leaders love talking about strategy, using words like strategic advantage, strategic intent, and strategic alignment. We often refer to “strategy” as if we have…

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10 Tips for Leading Successful Medical Device Development Projects

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…

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Common Regulatory Submission Pitfalls and Ways to Avoid Them

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…

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