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Improve Your Regulatory Submissions by Setting, Tracking, and Using the Right Metrics

There’s an adage that says what gets measured gets improved. Regulatory submissions are no exception. And with the growing complexity of clinical trials and increasing…

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Make the Case for Crisis Management Before the Crisis

Most people would agree that it’s better to prevent a crisis than to have to deal with one. But the reality is, by their nature,…

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Preventing and Managing Disruptive Compliance Challenges

Compliance challenges can create significant problems for life sciences organizations. Warning letters, consent decrees, product recalls, regulatory inspections, supply chain disruptions, and other crises have…

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MedTech Compliance Crises: Avoiding, Preparing for, and Learning from Disruptive Events

This article was originally published on MasterControl’s GxP Lifeline blog as How to Avoid—but Prepare for—Compliance Crises. What happens when a medical technology company gets…

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Disruptive Events: How Medical Device Companies Can Deal with Them Head on and Learn for the Future

Read the article below or download the complete PDF: "Don't Let a Crisis Become a Disaster" → When you hear “crisis,” you think “COVID.” But a…

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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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Steps to Accelerate Successful EU MDR Compliance

This article has been updated to indicate that the European Union Medical Device Regulation deadline has been extended one year, until May 26, 2021.  According…

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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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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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