Inspected.
Approved.
Proven Quality.

Quality and regulatory compliance are built into every stage of the ROIS manufacturing process. From independently verified laboratories providing analytical and microbiological testing to a manufacturing network inspected and approved by agencies including the U.S. FDA, EMA, PMDA, ANVISA, MHRA and KFDA.

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Quality assurance / labs

ROIS supports product quality, regulatory compliance and commercial supply readiness across sterile injectables, oral solid dose, high-potent compounds and drug-device combination products.

ROIS laboratories provide analytical, microbiological and stability testing using methods including HPLC, UPLC, GC, HVLD and spectroscopy, all in compliance with current USP and Ph. Eur. requirements.

Regulatory certifications

The ROIS network has been inspected and approved by agencies including the U.S. FDA, EMA, PMDA, ANVISA, MHRA and KFDA, supporting commercial supply into over 75 countries.

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Sterile fill-finish

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.

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Cytotoxic filling and lyophilization

With OEB5 containment, commercial-scale vial filling, lyophilization and integrated packaging capabilities, ROIS is the ideal manufacturing partner for complex cytotoxic and ADC programs.

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Packaging and integrated services

End-to-end support spanning analytical studies, packaging, device assembly, storage and logistics; ROIS simplifies project complexity with end-to-end solutions.

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