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.

Medical Information in the Netherlands: Safeguarding Compliance and Patient Confidence

Access to trustworthy pharmaceutical information is essential for patient safety and informed decision-making. In the Netherlands, medical information (MI) services are central to this goal, providing healthcare professionals, patients, and caregivers with accurate, non-promotional product...

Hand writing on clipboard with a pen

Regulatory Sciences

How a Strong Regulatory Strategy Supports Your Product’s Success

One of the big questions pharmaceutical, biotech and medical device companies often ask, is: “When is the optimal time to seek strategic regulatory consulting assistance?”. Traditionally, the need...

Woman wearing headset at a technology enabled tech call center

Medical Information

Risks to Consider when Implementing AI Technology in Medical Information

AI is a highly praised tool to implement across industries and service lines and Medical Information (MI) is no exception. In Medical Information, AI is embedded in a workflow for patients and...

Regulatory Sciences

FDA Drug Labeling Requirements & Regulations: What’s in Your Label?

Why Does Pharmaceutical Product Labeling Matter? Do you know what’s in your product’s labeling and what it is saying about your product? More importantly, do you know why that matters? A drug’s label...

Hands typing on a keyboard

Pharmacovigilance

Common Challenges in Signal Detection in Pharmacovigilance and How to Overcome Them

In pharmacovigilance, recognizing and responding to safety signals quickly can be crucial for patient safety. A "signal" in pharmacovigilance refers to a hypothesis, supported by evidence, of a new...

Clinical Research Solutions

Digital Transformation in Life Sciences: The Importance of Data Strategy

What is Digital Transformation? While there are many different definitions of digital transformation in life sciences, the core concepts they all have in common are digital technology and creating...

Regulatory Sciences

FDA eSTAR Template: Navigating FDA's 510(k) Submission Requirements

Implementing the eSTAR Format The eSTAR template is a positive step for both CDRH and medical device Sponsors; but, as with any new tool, there are challenges to utilizing the template. Sponsors need...

Several business professionals talking around glass conference table

Pharmacovigilance

Safety Data Exchange Agreements (SDEAs) and Pharmacovigilance Agreements (PVAs) – An Overview

A Safety Data Exchange Agreement (SDEA) or Pharmacovigilance Agreement (PVA) is a legal written contract which ensures that all safety data, PV tasks and responsibilities are detailed between two or...

Meet the Expert: Dana E. Vanderwall

Digital Transformation

Meet the Expert: Dana E. Vanderwall, PhD.

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...

Hand with pen preparing FDA regulatory documents

Regulatory Sciences

Regulatory Chemistry, Manufacturing, and Controls (CMC): What to Expect During Drug Development

The key to successful drug development in the US is directional and focused navigation of FDA’s Investigational New Drug (IND) process. The Chemistry, Manufacturing, and Controls (CMC) section is a...

Health care worker with a patient in a home

FSP Solutions

What is the FSP Model in Clinical Research?

The term Functional Service Provider (FSP) concept is highly regarded in the field of clinical research. With drug discovery and clinical trials becoming more complex, pharmaceutical firms and...

Meet the Expert: Tariq Khan

Pharmacovigilance

Meet the Expert: Tariq Khan

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

FDA Animal Rule: Overview & Impact on Drug Development

What is the Animal Rule? The Animal Rule, a regulation set by the US Food and Drug Administration (FDA), applies to the development and testing of drugs and biological products intended to reduce or...

Healthcare workers sharing a tablet device data with a coworker

Digital Transformation

ELN Software Selection: Finding the Right Solution for Your Business

Electronic lab notebooks (ELNs) are now well established in the pharma/life sciences industry but with such a wide variety of options to choose from, how do you find the right solution for your...

Meet the Expert: Terri Levine

Clinical Research Solutions

Meet the Expert: Terri Levine

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 typing on laptop displaying diagram of DNA double helix

Regulatory Sciences

The Moving Regulatory Landscape for Gene Therapy Trials in EU: Part 2

Change in the Submission of the Summary Notification Information Format The Summary Notification Information Format Form As of January 31, 2023, Sponsors are required to submit a Clinical Trial...

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...

Hands working on a laptop.

FDA's Expedited Programs Explained

In order to incentivize the development of therapies (drugs biologics) to fill unmet medical needs for treatment of serious conditions, the FDA has developed various programs to expedite drug...

Healthcare worker showing a woman details on a tablet device.

What are Patient Support Programs?

Patient Support Programs (PSPs)  in the pharmaceutical sector offer a range of services to help patients start and adhere to their therapies, including Patient Assistance Programs (PAPs), patient...

Several business professionals talking around glass conference table

Safety Data Exchange Agreements (SDEAs) and Pharmacovigilance Agreements (PVAs) – An Overview

A Safety Data Exchange Agreement (SDEA) or Pharmacovigilance Agreement (PVA) is a legal written contract which ensures that all safety data, PV tasks and responsibilities are detailed between two or...

Low angle of the United States Capitol Building

The Impact of a US Government Shutdown on the Food and Drug Administration

This article was originally published in September 2023, and has been updated to reflect an upcoming potential government shutdown. As U.S. lawmakers return from the President’s Day holiday, they are...

Casually dressed business professionals discussing intensely at a conference table

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...