Arcinova provides innovative research, development, and manufacturing services to advance drug development. Through a focus on quality, science, and innovation, we empower biotech and pharma to bring life-changing therapies to patients faster.

A robust Chemistry, Manufacturing and Controls (CMC) strategy—and the authoring of a complete, regulatory ready CMC dossier—is critical to securing regulatory approval and progressing safely into the clinic. At Arcinova, we author the CMC dossier as an integral part of our end to end Drug Substance and Drug Product development services. We take full responsibility for IND and IMPD documentation, delivering submission-ready content aligned with global regulatory expectations and first-in-human timelines.