Top three worldwide capacity in sterile fill-finish manufacturing

Supporting end-to-end late-phase and commercial manufacturing for complex injectable drug products across prefilled syringes, cartridges and vials, with specialized expertise in biologics, segregated cytotoxic lyophilization and ADC fill-finish, plus downstream services including packaging, device assembly and quality release.

Get in touch

End-to-end sterile fill-finish capabilities

ROIS supports late-phase and commercial injectable manufacturing with integrated capabilities spanning prefilled syringes, cartridges and vials, sterile manufacturing technologies from RABS to Isolator processing, and downstream packaging and device assembly.

A dedicated US-based facility adds specialized expertise in OEB5 cytotoxic manufacturing, complementing an Annex 1-compliant network that has hosted inspections from FDA, EMA and other leading global regulatory authorities.

Program support at every stage

Multiple formats

PFS, cartridges and vials

Flexible capacity

Scalable manufacturing from late-phase through commercial supply

Quality-led manufacturing

Proven quality systems and global regulatory approvals

Complex drug products, manufactured at scale.

Manufacturing complex injectable drug products at commercial scale demands proven expertise. ROIS is a single, accountable manufacturing partner, simplifying complexity to bring quality medicines to patients worldwide.

Get in touch