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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 Launches Crackdown on Deceptive Drug Advertising

On September 9, 2025, the US Department of Health and Human Services (HHS) and FDA unveiled a sweeping effort to clamp down on misleading direct-to-consumer (DTC) pharmaceutical advertising. The Agency announced it would:

Quality & Compliance

The Joint Commission Adds Pharmacists to Survey Teams: A Step Towards Comprehensive Healthcare Quality

In recent years, healthcare has undergone rapid transformation, especially in how care is delivered, measured, and improved. One of the most significant players in ensuring quality healthcare...

White pills behind magnifying glass

Regulatory Sciences

FDA's Commissioner’s National Priority Voucher (CNPV) Pilot Program Overview

An inside look at FDA's new Commissioner's National Priority Voucher (CNPV) pilot program—what it is, why it matters, and how regulatory and development teams can leverage it to accelerate...

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Quality & Compliance

Tech Transfer Readiness: Big Responsibility, Greater Reward

So, you're thinking about Technology Transfers (i.e., TT or Tech Transfer)? This question may look familiar to you. That is because we asked this very question in the first installment of our Tech...

professionals meeting at conference table to discuss fda submission for medical device

Regulatory Sciences

Navigating FDA's Q-Submission Process: A Strategic Advantage for Medical Device Developers

In the highly regulated medical device industry, navigating FDA's submission process can be daunting, especially for start-ups. However, FDA's Q-Submission (Q-Sub) program offers a valuable...

Medical Information

From Discovery to Discontinuation: How Medical Information Supports Every Stage

The journey from compound discovery to market-ready pharmaceutical product is long, complex, and resource-intensive. Only about 1 in 5,000 drug candidates make it to patients1, underscoring the need...

Quality & Compliance

Technology Transfer Projects: Assessing Need and Readiness

So, you're thinking about Technology Transfers (i.e., TT, Tech Transfer)? Who can blame you? There has been a significant amount of news recently regarding tariffs and the potential for bringing...

Person wearing protective equipment reviewing a tablet device

Quality & Compliance

15 Days of Panic Revisited: You Received an FDA Form or 483 Form Warning Letter, Now What?

Remember the last time you were pulled over by law enforcement? Maybe it was for a broken taillight or driving a few miles over the speed limit. Even if you believed you hadn't done anything wrong,...

Regulatory Sciences

Expanding into Europe? Accelerate Your European Marketing Authorization

For non-European pharmaceutical companies, expanding into the European market is both an exciting opportunity and a formidable challenge. While the potential for growth is significant, so too are the...

Regulatory Sciences

Navigating the German Pharmaceutical Landscape: Part Two

Market Access, Pricing, and Additional Compliance Considerations In part one, we explored the German pharmaceutical market and regulatory compliance requirements. Now, in part two, we will focus on...

Health care worker wearing headset working on laptop

Medical Information

How Multilingual Medical Information Services Enhanced Patient Safety During the COVID-19 Pandemic

The COVID-19 pandemic challenged nearly every aspect of healthcare delivery—and medical information (MI) services were no exception. As patients and healthcare professionals (HCPs) urgently sought...

Regulatory Sciences

Navigating the German Pharmaceutical Landscape: Part One

Regulatory Considerations and Market Entry Germany is home to one of the most advanced healthcare systems in the world, making it an attractive but complex market for pharmaceutical companies. A...

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Medical Information

Breaking Language Barriers: The Power of Multilingual Medical Information Services

In the dynamic and ever-evolving pharmaceutical industry, the provision of accurate and reliable Medical Information services (MI) is paramount. These services are crucial for healthcare...

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Pharmacovigilance

Understanding the Role of the Local Person for Pharmacovigilance (LPPV) in the Netherlands

For Marketing Authorisation Holders (MAHs) planning to market medicinal products in the Netherlands, compliance with local pharmacovigilance (PV) regulations is essential. At ProPharma, we understand...

Digital Transformation

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...

Regulatory Sciences

The Key to Understanding Pricing and Reimbursement in the Nordics

It is easy to think that when you finally receive market approval for your drug, you have reached the finish line. However, what many do not realize is that there is still a final hurdle that can be...

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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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...

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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...

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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...

The QPPV: An Essential Guide to the Qualified Person Responsible for Pharmacovigilance

When submitting marketing authorisation applications (MAAs) in Europe, the applicant (Marketing Authorization Holder, MAH) shall already have set up a pharmacovigilance system. A Summary of the...