Meet the Expert: Mukul Agrawal

Meet the Expert: Mukul Agrawal

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...

Medical professionals working together at a desk

2023: A New Chapter in FDA Drug Approvals - A Resurgence of Innovation

The year 2023 unveiled an eventful chapter in FDA drug approvals, heralding a resurgence of innovation after a brief decline. This period represented not just a numerical rebound but a meaningful...

Healthcare providers pointing to a tablet device

Regulatory Sciences

UK/EU Regulatory Developments Review 2023

Introduction The year 2023 has been remarkable in terms of regulatory developments within the UK and EU, characterised by substantial changes, innovative approvals, and strategic initiatives in the...

Meet the Expert: Dr. Kiran Kandula

Meet the Expert: Dr. Kiran Kandula

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: Philip Simonson

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...

Professionals reviewing graphs on paper

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...

Meet the Expert: Clarence Young, MD

Meet the Expert: Clarence Young

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...

Hands communicating across a desk while creating projects

The Hidden Costs of Project Communication Gaps

Ineffective communication may be a key factor contributing to the challenges in your projects. Communication is a vital aspect of our daily lives, and the success of a project is closely linked to...

Meet the Expert Brian Wellins

Meet the Expert: Brian Wellins

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...

FDA Proposes Significant Changes to LDT Regulation

On October 3rd, 2023, the U.S. Food and Drug Administration (FDA) issued a proposed rule to amend its enforcement approach to Laboratory Developed tests (LDTs). If implemented, this rule would result...

Medical device on table

FDA Finalizes the Breakthrough Devices Program Guidance and Reinforces Innovative Medical Device Manufacturers that Help to Address Health Inequities

The FDA's Breakthrough Devices Program is intended to expedite the development of innovative technologies for patients with life-threatening or irreversibly debilitating diseases or conditions. The...

Meet the Expert: Immaculich Rani

Meet the Expert: Immaculich Rani

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...

Woman looking into microscope in a laboratory.

Single Arm Trials: How to Make the Future Brighter

Randomized clinical trials (RCTs) are widely recognized as the gold standard for clinical and regulatory decision-making. Indeed, RCTs would be required in most cases, in particular when modest...

Meet the Expert: Steve Silverman

Meet the Expert: Steve Silverman

Expert Consultant, Regulatory Sciences 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...

EU Flags outside building

Clinical Research Solutions

Navigating Expedited Regulatory Pathways in Europe: The Latest Insights and Advancements

Are you truly up to speed on the most effective strategies to expedite the approval process for your innovative product in Europe's evolving regulatory landscape? In the United States (US), the Food...

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...