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.
Navigating FDA Layoffs: How Policy Layoffs May Impact Generic Drug Development
Layoffs at the Office of Generic Drug Policy Could Slow Development—but Strategic Guidance Can Help Sponsors Stay on Track
Navigating FDA Layoffs: OPDP Cuts and the Rising Stakes of Ad Compliance
The Importance of Compliance in Prescription Drug Advertising Amid Cuts to the Office of Prescription Drug Promotion The Office of Prescription Drug Promotion (OPDP), a key Office of the U.S. Food...
Success in the European Pharmaceutical Market: Part Two
In part one, we covered the regulatory framework, compliance, and Wholesale Distribution Authorization. In part two, we’ll explore how success in Europe goes beyond regulatory approval—it’s also...
The Role of the Local Person Responsible for Pharmacovigilance (LPPV) in the DACHL Region
Ensuring patient safety and compliance with pharmacovigilance (PV) regulations is a critical responsibility for marketing authorization holders (MAHs). For companies planning to market their...
Success in the European Pharmaceutical Market: Part One
According to the European Federation of Pharmaceutical Industries and Associations, Europe is the second-largest pharmaceutical market in the world. Therefore, it is not surprising that many biotech...
Key Steps to Creating a Successful Market Access Strategy
Understanding Health Technology Assessment (HTA) authorities’ requirements throughout the product development phase is crucial for a successful market access strategy and planning. This will increase...
Adapting Technology Transfer Strategies in Pharmaceutical Manufacturing Amidst New Tariff Regulations
The US Government recently modified their policy to utilize tariffs to in an effort to support the US economy causing many global organizations to investigate the consequences of the tariffs on their...
Navigating the Impact of New Tariffs: Strategies for Success Amidst Recent Trade Policy Changes
The US Government recently modified their policy to utilize tariffs to in an effort to support the US economy. Significant changes have been announced causing many global organizations to investigate...
Navigating a Shifting Regulatory Landscape: The Impact of FDA Layoffs on Medical Device Developers
On Thursday, March 27, 2025, HHS announced that they would be conducting a reduction in force impacting nearly 3,500 full time FDA employees – nearly 20% of the Agency’s entire workforce. This comes...
Navigating the Transition from ICH E6 (R2) to (R3)
Ensuring Compliance with ProPharma's Expert Support The global regulatory landscape for clinical trials continues to evolve to keep pace with technological advancements, risk management, and the...
