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Articles

Working Together to Accelerate Regulatory Submissions

“How can we submit sooner?” It’s long been the most common question a regulatory submissions team hears. Executive leaders have ambitious goals in mind for…

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Articles

8 Challenges to EU MDR Compliance and How to Tackle Them

Some good news: In March, final product safety certification deadlines were extended until 2027 or 2028 depending on the device class for European Union Medical…

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Case Studies

Putting the Pieces in Place to Support IND Submissions — and an IPO

Drug discovery, development, and commercialization is like a puzzle. The end may be easy to visualize, but there are many pieces that need to be…

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Articles

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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Blog

Make the Case for Crisis Management Before the Crisis

By Carl Manthe, Director, Integrated Project Management Company, Inc. Most people would agree that it’s better to prevent a crisis than to have to deal…

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Video

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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Articles

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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Articles

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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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

Steps to Accelerate Successful EU MDR Compliance

In March 2023, the European Commission got approval to extend the European Union Medical Device Regulation (EU MDR) deadline, which is a relief for patients…

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