regulatory sciences

Colleagues collaborating around a laptop

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...

Colleagues collaborating around a laptop

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...

Hands and pens pointing to papers and post-it notes

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...

Business Professionals Having Stressful Meeting

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....

European Union Flags Flying In Front Of Building in Brussels

Clinical Research Solutions

Navigating the New EU Health Technology Assessment Regulation (HTAR): Are You Ready?

The HTAR in the EU has come into force – what Health Technology Developers (HTDs) need to know Getting your health technology product to the market is complex and usually consists of several steps...

child-receiving-medical-care-rare-disease

Regulatory Sciences

The End of the FDA's Rare Pediatric Disease Priority Review Voucher Program

What’s Next for Rare Disease Innovation? For children suffering from rare and often life-threatening diseases, access to new and effective treatments can mean the difference between life and death....

Regulatory Sciences

Leveraging Single-Arm Trials for Regulatory Approval: Insights from EMA's Reflection Paper

The pharmaceutical industry has shown a growing interest in single-arm trials due to their potential to expedite drug development. However, several challenges and concerns remain. The European...

Regulatory Sciences

Drug Development: The Key to Success from Concept to US Commercialization

Congratulations! You have a lead candidate formulation for your new drug. You might be thinking to yourself, “okay, now what?” We all know the science and effort to get to this stage is significant....

Prev 1 2 3 4 5