Regulatory Sciences

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 The FDA has recently undergone a wave of layoffs that are beginning to...

Regulatory Sciences

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...

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Clinical Research Solutions

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...

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Pharmacovigilance

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...

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Clinical Research Solutions

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...

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Regulatory Sciences

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...

Quality & Compliance

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...

Quality & Compliance

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...

Woman calling medical information team.

Medical Information

Medical Information in the UK: Ensuring Compliance, Patient Safety, and Trust

In the highly regulated world of pharmaceuticals, medical information (MI) services play a critical role in ensuring that healthcare professionals, patients, and the public have access to accurate...

Regulatory Sciences

Scientific Data Works: Using Science to Navigate the Global Regulatory Maze

You’re developing an FDA – and/or EMA-regulated drug, biologic, or medical device. Throughout the drug development process, your goal is to get to the next regulatory milestone in the most...

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