When developing a generic drug, one of the critical steps is identifying and sourcing the right Reference Listed Drug (RLD). But what exactly is an RLD, and why does RLD sourcing matter so much for generic drug development? Let’s understand it through this blog. What is a Reference Listed Drug (RLD)? A Reference Listed Drug…

Biosimilars and generics are both affordable alternatives to brand-name medications. These drugs play a crucial role in expanding patient access to life-saving treatments. While both generics and biosimilars serve the same purpose, they represent fundamentally different products with distinct regulatory pathways. Understanding these differences is essential for pharmaceutical sponsors navigating the complex approval process and…

The year 2024 proved to be a turning point for pharmaceutical innovation. From oncology to metabolic and respiratory disorders, a new wave of therapies is redefining treatment paradigms. These therapies are creating significant market opportunities for generic challengers. Ten regulatory agencies-approved drugs are already being called the next generation of blockbusters, with each projected to…

When it comes to drugs, one of the most common questions patients ask is, Are generic drugs as effective as branded ones? Despite decades of clinical evidence and strict global regulations, myths about generic drugs continue to circulate, often creating unnecessary hesitation and confusion. In reality, generic drugs play a vital role in making healthcare…

Serialization was once a regulatory checkbox. Today, it’s the backbone of compliant, efficient, and transparent clinical trial supply management. Yet, many pharmaceutical companies continue to rely on legacy serialization systems that were built more than a decade ago. These systems can’t keep up with modern compliance demands, data interoperability, or global supply complexity. What was once…

This article, authored by our Founder Salim Shaikh in International Clinical Trial Magazine, explores how technology partnerships are reshaping clinical trials and building smarter, patient-centric supply chains. Clinical trials are evolving faster than ever before. They are driven by innovative technology partnerships that redefine how research reaches patients. From overcoming geographic barriers to improving patient…

Generic drugs are essential to global healthcare, making treatments more affordable and accessible to the audience. They account for over 90% of prescriptions in the U.S. market and about two-thirds in the European market. However, developing a generic isn’t just about copying a brand drug; it requires strict bioequivalence (BE) studies to prove the generic…

Ever wondered why some clinical trials get delayed even before patient recruitment begins? One of the biggest culprits is inefficient comparator drug sourcing. Comparator sourcing seems quite straightforward, but it is often riddled with misconceptions. It's very natural to believe that it’s just about “buying the drug,” but in reality, it is a complex yet…

Selecting the right clinical trial supplier is a crucial step that can make or break the success of your clinical research. In a competitive landscape with over 50,000 pharma and biotech firms globally, choosing a reliable partner for clinical trial supplies has never been more critical. This comprehensive guide sheds light on factors, processes, and…

When filing an NCE-1 application, being the first applicant to do so is not just a badge of honor; it also gives a strategic edge. The Para IV filing offers exclusive opportunities to dominate the market before competitors enter the scene. Despite this lucrative benefit, common myths persist, clouding judgment, delaying action, and costing companies…