Regulatory Sciences
Navigating the German Pharmaceutical Landscape: Part One
Regulatory Considerations and Market Entry Germany is home to one of the most advanced healthcare systems in the world, making it an attractive but complex market for pharmaceutical companies. A...
Regulatory Sciences
The Key to Understanding Pricing and Reimbursement in the Nordics
It is easy to think that when you finally receive market approval for your drug, you have reached the finish line. However, what many do not realize is that there is still a final hurdle that can be...
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...
Regulatory Sciences
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...
Regulatory Sciences
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...
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...
Regulatory Sciences
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...
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...
Regulatory Sciences
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....