Clinical Research Solutions
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...
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...
Clinical Research Solutions
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...
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...
Clinical Research Solutions
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...
Clinical Research Solutions
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...
Clinical Research Solutions
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...
Clinical Research Solutions
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...
Clinical Research Solutions
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...
Clinical Research Solutions
FAQs: Model Informed Drug Development (MIDD) & Modeling and Simulation (M&S)
Question & Answer with Sander Vinks, PhD, PharmD, FCP, Regarding MIDD and M&S In the ever-evolving landscape of drug development, efficiency, precision, and regulatory success are paramount....