Preventing and Managing Disruptive Compliance Challenges

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…

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…

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…

“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…

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…

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,…

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…

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…

The good news is that the FDA is enhancing review processes to ensure medical devices are safer and more effective. But are your new products…