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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...

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Quality & Compliance

Dealing with API and Excipients in a Time of Tariffs

The US Government recently modified its policy to utilize tariffs to support the US economy. Pharmaceutical tariffs have been forecasted, causing many global organizations to investigate the...

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Regulatory Sciences

FDA's "Radical Transparency" Shift: What Regulatory Pros Need to Know

A New Era of FDA Disclosure On Thursday, July 10, 2025, FDA published more than 200 decision letters, known as complete response letters (CRLs). The CRLs were issued in response to applications...

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Medical Information

Medical Information Contact Center: The Silent Revolution

Medical Information Contact Centers have long operated behind the scenes, connecting pharmaceutical companies, healthcare professionals, and patients through phone and email to provide product...

Regulatory Sciences

Leveraging Online FDA Information to Accelerate ANDA Timelines

In the race to generic drug approval, timing is everything. Delays in Abbreviated New Drug Application (ANDA) submissions or setbacks during FDA review can mean missed market opportunities,...

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Regulatory Sciences

Maximizing the Value of FDA Pre-IND Meetings for Successful 505(b)(2) NDA Submissions

For drug developers leveraging the 505(b)(2) pathway, the FDA Pre-Investigational New Drug (Pre-IND) meeting is a strategic opportunity that can shape the trajectory of an entire development program....

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...

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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...

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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...

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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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...

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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...