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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Clinical Research Solutions

Success in the European Pharmaceutical Market: Part One

According to the European Federation of Pharmaceutical Industries and Associations, Europe is the second-largest pharmaceutical market in the world. Therefore, it is not surprising that many biotech...

Quality & Compliance

Adapting Technology Transfer Strategies in Pharmaceutical Manufacturing Amidst New Tariff Regulations

The US Government recently modified their policy to utilize tariffs to in an effort to support the US economy causing many global organizations to investigate the consequences of the tariffs on their...

Quality & Compliance

Navigating the Impact of New Tariffs: Strategies for Success Amidst Recent Trade Policy Changes

The US Government recently modified their policy to utilize tariffs to in an effort to support the US economy. Significant changes have been announced causing many global organizations to investigate...

Quality & Compliance

Navigating the Transition from ICH E6 (R2) to (R3)

Ensuring Compliance with ProPharma's Expert Support The global regulatory landscape for clinical trials continues to evolve to keep pace with technological advancements, risk management, and the...

Quality & Compliance

Staying Ahead: Why BIMO Inspection Readiness Audits Are Essential for Clinical and Biological Research Compliance

In the world of clinical and biological research programs, ensuring compliance with regulatory standards is not only essential for maintaining the integrity of studies but also for safeguarding the...

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Quality & Compliance

Pre-Approval Inspection (PAI) Readiness is Easy, Right?

Facing a pending filing and subsequent PAI can feel overwhelming, no matter if you are a young firm or an established company. You're balancing the excitement of bringing a new product to market with...

Quality & Compliance

WHO Issues Guidance on Antibiotic Pollution Control

On September 3, 2024, the World Health Organization (WHO) released its first guidance to mitigate antibiotic pollution from manufacturing. This directive, which outlines wastewater and solid waste...

Quality & Compliance

The Evolving Landscape of Quality Management Systems in the Life Sciences Industry

In the decades since the FDA first introduced Good Manufacturing Practice (GMP) regulations, the drug and device industry has undergone significant transformation. While the core principles of...

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Quality & Compliance

Breaking the Chains of Project Management Dysfunction

Right now, you are sitting in front of your computer and wondering how, based on current project status, you will achieve your remaining project goals for the year or achieve those planned for the...

Meet the Expert: Andrew Bright

Quality & Compliance

Meet the Expert: Andrew Bright

Our "Meet the Expert" series introduces you to our team of experts around the world. This "behind the curtain" view will help you get to know who we are on a professional and personal level, and...

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