thought leadership

ProPharma’s team of dedicated experts is at the forefront of both existing and emerging industry trends. ProPharma’s team inspires tomorrow by leveraging rich data insights across our service lines and functional areas to develop innovative solutions that answer the most complex needs of both existing and prospective clients.

FDA Meetings Lab Developed Tests

November 14, 2023

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 Devices FDA Guidance

November 13, 2023

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 Clinical Research Solutions

November 9, 2023

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...

Regulatory Sciences Clinical Trials

November 8, 2023

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 Regulatory Sciences

November 2, 2023

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...

EMA PRIME

October 30, 2023

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...

Quality & Compliance Quality Assurance

October 27, 2023

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...

Meet the Expert Medical Information

October 26, 2023

Meet the Expert: Janice Worley

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...

Quality & Compliance GxP

October 23, 2023

Recognizing the Value of Outsourcing GxP Audits

In today's highly regulated pharmaceutical, biotechnology, and healthcare industries, maintaining compliance with GxP Practices, and other regulatory requirements is paramount. Failure to meet these...

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Inspiring the Future of Drug Development

We’ve developed a process that suits the today’s needs and a better experience for clients. Our industry is constantly changing. Let us help you accelerate your innovation.