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For years, CMC was seen as the quiet support function: documenting processes, reacting to clinical needs, and staying behind the scenes. That model no longer works. Today, CMC shapes whether development succeeds—or stalls . Accelerated pathways, complex biologics, and global regulatory expectations mean that late-stage CMC issues can halt programs, delay approvals, or limit commercial potential. We see that organizations excelling in CMC: Integrate CMC leadership into early a

In the world of drug development, one of the simplest tools for reducing risk is also one of the most under-used: asking regulators direct questions. Whether it’s a clarification on an FDA expectation, an EDQM CEP procedure nuance, or a grey-zone interpretation of ICH guidance, development teams often sit on important questions far too long. This is repeated — smart teams hesitating to reach out, worried about “looking unprepared,” “triggering scrutiny,” or “committing to a p

Early investment in a sound CMC strategy, aligned with ICH and FDA guidance, accelerates development timelines and reduces regulatory risk.

In the ever-changing world of pharmaceuticals, mastering regulatory affairs is not just a necessity, it is a pathway to success.