Our comprehensive service offering includes the capability for producing sterile drug products, utilising full disposable systems and meeting rigorous sterility requirements in accordance with aseptic manufacturing procedures.
With batch sizes from 1 to 100 litres, Cobra can manufacture for clinical trials through to commercial scale supply, with parenteral products filled in single-use syringes or injected vials.
All batch records are fully traceable under QA observation
with QP review and issue of cGMP Certificate of Compliance, and regulatory documents are reviewed as required to support product release to clinic. Primary labelling of drug product vials for human clinical centres, secondary packaging and labelling of vials for dispatch to clinical centres, and tertiary and transport labelling and packaging can also be arranged according to regulatory requirements.
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