Latest Developments and Insights

Navigating the regulatory landscape is a critical step in the development of biopharmaceutical products. Biologics License Applications (BLAs) and New Drug Applications (NDAs) are two distinct drug marketing applications and approval pathways designed for biologics and small-molecule drugs (traditional drug…

In the ever-evolving landscape of cancer treatment, timely access to effective therapies is crucial. The FDA’s Real-Time Oncology Review (RTOR) program is a groundbreaking initiative designed to expedite the review process for oncology drugs and biologics ensuring that patients receive…

The CMC consultant’s critical role in successful regulatory submissions cannot be overlooked in the biopharma industry, which requires meticulous attention to Chemistry, Manufacturing, and Controls (CMC) standards to achieve product approval. CMC consultants play a crucial role in meeting these…

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…