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...
Quality & Compliance
Building Clinical Quality Assurance: Unlock the Full Potential of Your Clinical Development
In the dynamic world of pharmaceuticals and biotechnology, small Sponsor companies are often the unsung heroes driving innovative therapies through the complex journey from concept to clinic. With...
Quality & Compliance
Ensuring Quality in Clinical-Phase Drug Manufacturing: A Comprehensive Guide
Importance of Quality Assurance in Clinical-Phase Drug Manufacturing Quality Assurance (QA) is a critical function in the pharmaceutical industry, ensuring that every aspect of drug manufacturing...
Demystifying CAPA Management: Overcoming Challenges in the Fast-Paced World of GMP
This article has been updated since its original publication date. Navigating the complexities of Corrective Action / Preventive Action (CAPA) in the drug and medical device industries often poses a...
How to Give Quality Assurance the Respect It Deserves During a Post-Merger Integration
A typical post-merger integration (PMI) between two companies is challenging, time-consuming, stressful, and resource intensive. Even the companies most experienced with integration find these...
Quality & Compliance
What is Software Quality Assurance (SQA) and Do You Need it For Your Business?
If your only method of quality assurance is software testing, you're wasting valuable time and resources. Software Quality Assurance (SQA) is integrated into your software development life cycle to...
Implementing a Risk-Based Supplier Management Program
According to recent FDA updates on the implementation of the Safety and Innovation Act (FDASIA), nearly 40 percent of finished drugs are being imported, and nearly 80 percent of active ingredients,...
Does Your Training Program Have Traction?
With the spotlight these days on Data Integrity, it may be easy to lose sight of some fundamental Quality Systems. Core Quality Systems include Document Management, Investigation Management, and...
Does your Quality System stand up to the challenge?
Implementing and maintaining a Quality System is a complex challenge. It is as much as an art as it is a science. A company’s Quality System establishes the framework to manage and maintain...
Gravity and Quality Assurance
As we’ve now moved on from another cold winter month, I was captivated recently thinking about Quality Assurance and our collective responsibilities. All kinds of things come to mind; Deviations,...