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.

Advances in AI for Digital Transformation: Insights from BioIT World 2025

While AI has been topping the agenda at most industry events for several years now, the progression from futuristic vision to nearly commodity capability was particularly apparent at BioIT World 2025. With four conference tracks focused on different types of AI and specialist exhibitors such as...

Medical Information

Excelling in the JAPAC Medical Information Landscape: Key Considerations and Insights

As a rapidly expanding market, the Japan and Asia-Pacific (JAPAC) region presents a unique and complex landscape for those who are looking to establish a medical information (MI) function. Having a...

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...

FDA Recommendations for Confirming an Ames Positive Finding

Regulatory Sciences

Nonclinical Drug Development: FDA Recommendations for Confirming an Ames Positive Finding

On November 27,2024, FDA released a draft guidance intended “to inform industry and the review staff in the Center for Drug Evaluation and Research (CDER) on how CDER views positive findings in the...

Navigating European Market Access & Reimbursement Strategy for Medical Devices and the Impact of HTAR

Regulatory Sciences

Navigating Market Access & Reimbursement Strategy for Medical Devices in Europe

Background Developing medical devices (MDs), including in vitro diagnostic medical devices (IVDs), requires careful and result-oriented planning throughout the development process. One critical...

final fda guidance ich m13A requirements

Regulatory Sciences

FDA Releases Final ICH M13A Guidance Document

On October 31, 2024, FDA issued its final version of the ICH M13A guidance for industry, titled “M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms”. This guideline provides...

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...

R&D Technology

Evolving at the Speed of Science: How to Future-Proof your Benchling Platform

Science and technology are evolving rapidly, with an explosion in machine learning (ML) and artificial intelligence (AI) creating new possibilities for scientific discovery, operational efficiencies,...

Woman extending arms enjoying sunset

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...

Medical Information

Checklist for Building a Successful Risk Evaluation and Mitigation Strategy (REMS) Program

What is REMS? A Risk Evaluation and Mitigation Strategy (REMS) is a critical component of modern pharmaceutical regulation, designed to ensure that medications with serious safety risks are used...

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