Regulatory Blog

In the evolving regulatory landscape of generic drug manufacturing, compliance and transparency  are more crucial than ever. The FDA’s...

As the role of real-world data (RWD)  and real-world evidence (RWE)  grows in drug development, regulatory decision-making, and...

Navigating the regulatory landscape for medicines in the UK can be complex, especially as requirements evolve and innovation accelerates....

The Medicines and Healthcare products Regulatory Agency (MHRA) published a key update on 17 June 2025 , outlining revised requirements...

The U.S. Food and Drug Administration (FDA) has released an updated guidance " ANDAs: Pre-Submission Facility Correspondence Related to...

The integration of real-world data (RWD) into regulatory decision-making is transforming the landscape of pharmaceutical development and...

In recent years, GLP-1 receptor agonists have gained widespread attention for their dual role in type 2 diabetes management and weight...

In the evolving landscape of pharmaceutical manufacturing, Decentralised Manufacture  has emerged as a pivotal approach, especially in...

On June 2, 2025 , Swissmedic published a harmonised suite of guidance documents to standardise, streamline, and digitalise the clinical...

In a major step toward global harmonisation of clinical trial processes, the U.S. Food and Drug Administration (FDA) and the...

What if the agonizing wait for drug approvals could be slashed from days to minutes? Imagine a future where breakthrough therapies reach...

Developing drug products across multiple strengths is a common strategy in pharmaceutical formulation, allowing dose flexibility and...

A color additive is any dye, pigment, or substance that imparts color to a drug. Only color additives listed in FDA regulations are...

Pharmacovigilance is critical for ensuring drug safety in the EU. EudraVigilance is the central system operated by the European Medicines...

The integration of real-world data (RWD) in clinical research is revolutionizing the pharmaceutical landscape. The Medicines and...

Understanding and navigating the UK's regulatory requirements is crucial for pharmaceutical companies aiming to obtain marketing...

Companies increasingly turn to co-marketing partnerships in today’s highly competitive pharmaceutical landscape to expand product reach,...

The European Medicines Agency (EMA) has long committed to this principle through Policy 0070, which governs the publication of clinical...

In a globally interconnected pharmaceutical landscape, regulatory collaboration is essential to ensure timely patient access to safe and...

The U.S. Food and Drug Administration (FDA) has marked a significant milestone in its digital transformation journey by announcing the...