Clinical Research Solutions

What to Expect During the NDA Review Process

Compiling and submitting a New Drug Application (NDA) submission is a complicated and intensive activity. Once you have submitted your application to FDA, you may be curious about what can you expect...

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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...

Clinical Research Solutions

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...

Regulatory Sciences

Beyond the Trifecta: Best Practices for a Successful Promotional Review Committee (PRC) Process

To reduce frustration within a promotional review committee (PRC), the PRC must be a well-oiled machine firing on all cylinders and working at optimum capacity. How does a PRC achieve this? By...

Regulatory Sciences

The Trifecta of Promotional Review: What is a PRC & What do They Do?

The mystique of PRC unveiled – what is it and why you need it to assure successful promotional review. You have received approval from the regulators. You have a dynamic sales force in place. They...

Clinical Research Solutions

Meet the Expert: Sarah Giorgio

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

EU Pharmaceutical Legislation Reform: Where Are We Now?

On April 26, 2023, the European Commission proposed a new package of pharmaceutical legislation1 to revise many of the currently applicable Regulations. Background This revision is considered by many...

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Clinical Research Solutions

Understanding PIPL: Compliance and Implementation Challenges

What is PIPL? Personal Information Protection Law (PIPL) was approved in China on August 20, 2021. It was the first comprehensive data protection legislation in the region. The Law entered into...

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Pharmacovigilance

Achieving Success with Regulatory Intelligence in Pharmacovigilance

What is Regulatory Intelligence in Pharmacovigilance? In Pharmacovigilance (PV), Regulatory Intelligence involves the collection and analysis of publicly accessible PV regulatory guidelines and...

Meet the Expert: Beverly Zhuge

Meet the Expert: Beverly Zhuge

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...

Meet the Expert: Rodrigo Perez

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

How Important is Biostatistics?

The link between statistical methods and healthcare is not a new one, but the volume of available data to inform healthcare decisions and the use of data science in the medical industry has exploded...

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Clinical Research Solutions

What are Quality Management Systems (QMS)?

What is Quality Management? Quality Management is the set of processes that enable delivery of high-quality products while maintaining regulatory compliance. Its purpose is to ensure that all...

People working at a table with medical and computer devices

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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Clinical Research Solutions

Formal FDA Meetings for Sponsors or Applications of PDUFA Products

This article has been updated since its original February 28, 2017 publication. Since the introduction of the Prescription Drug User Fee Act (PDUFA) VII for fiscal years 2023 - 2027, the FDA...