quality compliance

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Quality & Compliance

5 Key Challenges in the Development of Gene Therapies

Over three decades of gene therapy (GT) clinical trials have yielded many innovative and promising treatments for pernicious genetic disorders but industry has shown slow development and dashed...

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Quality & Compliance

A Guide to Solving Complex Life Sciences Challenges

Life sciences organizations are consistently inundated with decisions and challenges of varying scale. These can occur anywhere during the life sciences value chain, under any treatment modality...

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Quality & Compliance

How to Decentralize Cell and Gene Therapy Treatments

The Challenge: CAGT Treatments Require Time and Lack Availability Persons diagnosed with life threatening diseases which are now treatable with cell and gene therapies (CAGT) often needed to wait for...

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Quality & Compliance

Maximizing Cost Efficiency: The Financial Advantages of Outsourcing Vendor Audits

In today's dynamic business landscape, organizations in the drug, biologics, and medical device industries face the dual challenge of delivering quality products while managing tighter budgets and...

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Quality & Compliance

FDA Publishes Guidance for CAR T Products

In January 2024, the FDA Center for Biologics Evaluation and Research (CBER) Office of Therapeutic Products issued a guidance document- Considerations for the Development of Chimeric Antigen Receptor...

Quality & Compliance

The Importance of EU/UK QP Audits

In the highly regulated pharmaceutical industry, ensuring the safety, quality, and efficacy of medicinal products is paramount. One crucial aspect of this assurance lies in the oversight provided by...

Meet the Expert: Rodrigo Perez

Clinical Research Solutions

Meet the Expert: Rodrigo Perez

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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Clinical Research Solutions

Understanding GxP Compliance in Drug and Medical Device Development Lifecycle

In the complex world of drugs and medical devices, where every pill, syringe, and implant holds the potential to impact lives profoundly, ensuring the utmost safety, efficacy, and quality is...

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Quality & Compliance

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...

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Clinical Research Solutions

Value of Intentional Bias in GxP Vendor Audits

Discovering intentional bias in GxP Vendor audits: weighing its advantages, drawbacks, and strategies for effective mitigation. While the prevailing view suggests that GxP auditors should not be...

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