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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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Case Studies

A Focus on Collaboration Gets CMC Back on Track, Increasing Efficiency and Solidifying a Round of Funding

The product development timeline for a new pharmaceutical is fragile. If one link in the chain breaks, it delays everything else, including clinical trials, regulatory…

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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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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

How to Guide a Medtech M&A Integration to Achieve its Long-Term Benefits

Companies often begin achieving some business benefits of a merger or acquisition as soon as the two entities become one. And forward-looking organizations are eager…

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Articles

Key Value Drivers Get Your Combined Medtech Organization Rowing in the Same Direction

Successful mergers and acquisitions integrations depend on strong leadership and a consistent message of a compelling shared vision and strategy. Presumably, a sound strategy drove…

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Articles

A Successful Medtech M&A Integration Starts Long Before Day One

“Day One” is a key milestone in a merger or acquisition. The first day of legal ownership, Day One requires thorough planning to gain and…

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Articles

5 Guiding Principles for a Medtech M&A Integration

What do successful mergers and acquisitions (M&A) integrations have in common? Timely and thorough planning. Companies often either wait too long to begin planning or…

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Articles

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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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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