Latest Developments and Insights

Understanding how CMC consulting accelerates product development timelines is paramount in today’s fast-paced pharmaceutical landscape, accelerating drug development timelines is essential to bringing life-saving treatments to patients sooner. Chemistry, Manufacturing, and Controls (CMC) consulting provides strategic oversight across each stage…

As drug development advances, the role of Chemistry, Manufacturing, and Controls (CMC) trends in drug development are playing an increasingly critical role. New trends are emerging that streamline processes and meet the growing demand for innovative, sustainable, and personalized therapies.…

Gene and cell therapies are at the forefront of medical breakthroughs, offering new possibilities for treating complex diseases. The success of these therapies heavily relies on the meticulous processes involved in Chemistry, Manufacturing, and Controls (CMC). CMC plays a crucial…

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…