DSI Subject Matter Experts

Even with the best process design and operational controls, deviations in API manufacturing are inevitable. The real measure of a company's GMP maturity isn’t whether deviations occur—it’s how they are investigated, documented, and prevented from recurring.  Effective deviation management and root cause analysis (RCA) are critical for maintaining regulatory compliance, protecting product quality, and safeguarding clinical and commercial supply.  […]

In drug development, brilliant science alone doesn’t secure regulatory approval—or commercial success. Technical risks related to Chemistry, Manufacturing, and Controls (CMC), regulatory pathways, and manufacturing scalability are often the silent killers of otherwise promising programs.  For investors evaluating biotech opportunities, understanding how technical risk evolves from concept to approval is critical to making informed, strategic […]

When biotech companies seek funding—whether for a Series A, Series B, IPO, or strategic partnership—investors do not just look at clinical data. They also carefully review CMC information (Chemistry, Manufacturing, and Controls) to evaluate whether the product is manufacturable, scalable, and approvable.  CMC readiness can heavily influence investment decisions. Here’s what you need to know […]