Latest Developments and Insights

Bringing innovative therapies to market quickly is critical for treating serious medical conditions, and regulatory programs like the FDA’s Fast-Track and Breakthrough Therapy Designations offer a streamlined path to approval. These pathways allow companies to accelerate development and review by…

As gene therapy continues to evolve, it has the potential to transform medical treatment for a range of complex conditions. Alongside these advancements, the role of regulatory affairs has expanded so that these groundbreaking therapies meet the highest standards of…

In the first instalment of our multi-part series, the key differences between biologic drugs and traditional small molecule drugs such as active pharmaceutical ingredient source, molecular size, structural complexity and immunogenicity were introduced.  In this second instalment, we explore the…

In the dynamic landscape of biopharmaceutical development, adherence to evolving international standards is crucial. The recent updates from International Council for Harmonisation (ICH) Q2 “Validation of Analytical Procedures” from Revision 1 to Revision 2, coupled with the introduction of ICH…

In today’s highly regulated industries, compliance with regulatory standards is crucial for business success and public safety. Regulatory affairs professionals play a vital role in managing the complex processes involved in meeting these standards, from product development to market approval.…

The pharmaceutical landscape is governed by strict regulatory frameworks that focuses the safety and efficacy of medications. In the United States, two primary pathways exist for drug approval: the New Drug Application (NDA) and the Abbreviated New Drug Application (ANDA).…