5 CDMO Red Flags You Can’t Ignore: A Guide for Biotechs and Pharma

Selecting the right CDMO is one of the most important choices a biotech or pharma team will make. The right partner helps you move efficiently toward IND or IMPD, safeguard quality, and anticipate regulatory needs before they become roadblocks. The wrong one can mean delays, rising costs, and lost momentum.

At Exemplify BioPharma, a Symeres company, we’ve seen how easily programs can be set back when communication, scope, or regulatory expectations aren’t aligned. In fact, industry studies show that outsourcing challenges are among the top causes of missed development timelines.¹

Drawing on more than 30 years of integrated drug development and CMC experience across the Symeres network, this paper highlights the red flags that most often derail outsourced programs—and how to spot and prevent them before they impact your success.

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