quality compliance

Quality & Compliance ensures that life sciences organizations meet rigorous standards while delivering safe, effective products. Maintaining strong quality systems and ensuring regulatory compliance are essential to protecting patient safety. The articles featured here provide knowledge to support operational excellence and industry best practices.
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Quality & Compliance

FMEA Is Not a Crystal Ball: Why You're Missing Critical Risks in Medical Device Lifecycle Management

Imagine trying to predict how a medical device could cause harm—but you're only allowed to look at one failure at a time, with no context, interactions, or real-world complexity. It's like peering...

Conveyor belt manufacturing medicine vials

Quality & Compliance

FDA Audit Preparation 101: How to Prepare and Manage an FDA Inspection

Imagine for a moment that this is your current situation… You receive a frantic call from the receptionist at your facility. An Investigator1 from the Food and Drug Administration (FDA) has just...

A Robotic arm placing medicine bottles on conveyor belt in manufacturing facility.

Quality & Compliance

Dealing with API and Excipients in a Time of Tariffs

The US Government recently modified its policy to utilize tariffs to support the US economy. Pharmaceutical tariffs have been forecasted, causing many global organizations to investigate the...

Quality & Compliance

The Joint Commission Adds Pharmacists to Survey Teams: A Step Towards Comprehensive Healthcare Quality

In recent years, healthcare has undergone rapid transformation, especially in how care is delivered, measured, and improved. One of the most significant players in ensuring quality healthcare...

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Quality & Compliance

Tech Transfer Readiness: Big Responsibility, Greater Reward

So, you're thinking about Technology Transfers (i.e., TT or Tech Transfer)? This question may look familiar to you. That is because we asked this very question in the first installment of our Tech...

Quality & Compliance

Technology Transfer Projects: Assessing Need and Readiness

So, you're thinking about Technology Transfers (i.e., TT, Tech Transfer)? Who can blame you? There has been a significant amount of news recently regarding tariffs and the potential for bringing...

Person wearing protective equipment reviewing a tablet device

Quality & Compliance

15 Days of Panic Revisited: You Received an FDA Form or 483 Form Warning Letter, Now What?

Remember the last time you were pulled over by law enforcement? Maybe it was for a broken taillight or driving a few miles over the speed limit. Even if you believed you hadn't done anything wrong,...

Regulatory Sciences

Expanding into Europe? Accelerate Your European Marketing Authorization

For non-European pharmaceutical companies, expanding into the European market is both an exciting opportunity and a formidable challenge. While the potential for growth is significant, so too are the...

Regulatory Sciences

Navigating the German Pharmaceutical Landscape: Part Two

Market Access, Pricing, and Additional Compliance Considerations In part one, we explored the German pharmaceutical market and regulatory compliance requirements. Now, in part two, we will focus on...

Regulatory Sciences

Navigating the German Pharmaceutical Landscape: Part One

Regulatory Considerations and Market Entry Germany is home to one of the most advanced healthcare systems in the world, making it an attractive but complex market for pharmaceutical companies. A...

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