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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:

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Quality & Compliance

Creating an Effective Global Audit Strategy for Medical Device and Diagnostic Companies: A Tale of Two Paths

The Crossroads of Global Compliance For medical device and diagnostic companies operating in today’s global marketplace, success depends on more than just innovative products — it hinges on a...

Regulatory Sciences

Transparency Requirements and the Requirement for Document Redaction

In an era of increasing scrutiny and demand for transparency in clinical research, the European Union (EU) has taken significant strides to enhance public access to clinical trial data and ensure the...

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Regulatory Sciences

FDA to Release CRLs in Real Time: What Does This Mean for Drug Developers?

On September 4, 2025, FDA announced a sweeping policy change: the real-time release of Complete Response Letters (CRLs); a continuation of FDA's July 10, 2025 publication of previously undisclosed...

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Quality & Compliance

Why Project Management Is Essential, NOT a Luxury, for Today's Pharma Activities

When we meet with life sciences clients (especially small/mid-sized companies), Project Management (PM) is very rarely an area of importance. It is almost consistently an afterthought. Clients are...

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Medical Information

Balancing Efficiency and Quality in High Volume Medical Information Contact Centers

In the pharmaceutical and medical information space, contact centers serve as a vital bridge between healthcare professionals, patients, and the companies that manufacture and distribute...

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Regulatory Sciences

MAH Expertise Across Eastern Europe — and Beyond

Navigating pharmaceutical regulations across multiple countries isn't just about knowing the rules — it's about understanding the rhythm of each market, responding quickly to change, and having the...

Regulatory Sciences

MLR Submission Checklist: Preparing for Speed and Compliance

Pharmaceutical, biotech, and MedTech companies invest significant time and resources into developing promotional materials, only to face avoidable delays during the Medical, Legal, and Regulatory...

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Medical Information

Why MI Experts Can Reduce Operational Burden for Pharma Companies

In today's highly regulated pharmaceutical industry, Medical Information (MI) services are expected to do more than respond to inquiries; they must provide accurate, balanced, and scientifically...

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Regulatory Sciences

Maximizing Clinical Trial Success: Strategic Approaches for Adding EU Member States in CTIS

Strategic Guidance for Expanding Clinical Trials Across EU Member States with CTIS Expanding a clinical trial to additional Member States within the European Union (EU) Clinical Trial Regulation...

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Pharmacovigilance

Selecting a PMPV Vendor, Part II: Building on a Strong Foundation

Previously, we outlined the critical components to be considered when starting a clinical trial program (Safety Services: A Critical Component of Clinical Trials). In this second installment we'll be...

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Clinical Research Solutions

The Role of CROs in Clinical Research & Clinical Trials

Clinical trials are complex, resource-intensive, and heavily regulated endeavors that span months to years. For many pharmaceutical, biotechnology, and medical device companies, navigating this...

Regulatory Sciences

FDA Inspection Readiness: Top Observations and How to Avoid a Form 483

For medical device manufacturers, FDA inspections are a critical component of regulatory oversight and quality assurance. Whether part of a routine surveillance program, pre-approval inspection, or...

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FSP Solutions

Recruitment Strategies in FSP: Building Agile Teams to Drive Clinical Success

Staffing has become one of the most critical and complex challenges in the success of Functional Service Providers (FSP) within clinical research. Whether you're launching a global Phase III study or...

Regulatory Sciences

The Moving Regulatory Landscape for Gene Therapy Trials in EU

Submitting a GMO Application for a Clinical Trial with AAV Viral Vectors Navigating the regulatory landscape for clinical trials in the European Union (EU) has become more streamlined with the...

Medical Information

Orchestrating Excellence: How ProPharma Bridges Vendors to Deliver Unified, High-Quality Outcomes

Greater Than the Sum of its Parts An introspection on the complexities of ProPharma Medical Information working with clients and their other outside vendors. Drug development is rarely a one-company...

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...

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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...