Latest Developments and Insights

The submission of an IND or other global first-in-human regulatory filing represents a pivotal milestone in transforming scientific discoveries, known as new chemical entities, into potential medical breakthroughs. This process involves a comprehensive evaluation of drug candidates to ensure their…

What is process control? Process control is the backbone of precision in manufacturing, providing the framework needed to maintain quality, safety, and efficiency. In the biopharmaceutical industry, even minor deviations can have significant consequences; process control plays a vital role…

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…