Arcinova is a trusted CRDMO delivering integrated drug substance and drug product services to advance early‑stage drug development. We supply early‑phase clinical material using value‑driven, regulatory‑led CMC strategies that efficiently move molecules from concept to clinic. With deep pharmaceutical roots and a focus on scientific excellence, we keep biotech and pharma teams in control while accelerating the delivery of life‑changing therapies.

A robust Chemistry, Manufacturing and Controls (CMC) strategy and the delivery of a complete, regulatory ready CMC dossier are essential to securing regulatory approval and progressing safely into the clinic. No investigational product can be administered to humans without clear, defensible CMC assurance. 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 ownership of IND and IMPD documentation, delivering submission ready content aligned with global regulatory expectations and first-in-human timelines.