Contract manufacturing
BioSecure fills and seals sterile product in Research Triangle Park, North Carolina — then packages, labels and documents it, so it leaves with the paperwork already in order.
Aseptic fill suite · vials at the filling needles
Quality control
Quality control runs alongside production rather than after it. Samples are pulled, examined and recorded as the batch moves, so a result is never what the release is waiting on.
Labeling
A label carries the lot, the dates and the data the rest of the journey depends on. We print, apply and verify in line with the fill, so identity is fixed at the moment the product is sealed — not somewhere downstream.
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Packaging line · cartons into the case packer
Packaging
Primary and secondary packaging are handled in the same controlled environment as the fill, so the product stops changing hands between steps and the record stays continuous.
Regulatory support
Regulatory support means the paperwork is finished when the batch is — not the week before someone asks for it. Documentation is built as the work happens and kept ready between visits.
Batch records, specifications and certificates assembled into a single, coherent file set.
Technical files and dossiers prepared to the format the receiving market expects.
Written responses to questions from regulators drafted and tracked to their closure.
Records and site documentation kept inspection-ready in the gaps between visits.
Facility tours and capability calls
A facility tour walks the fill suite, the QC lab and the packaging floor. A capability call starts with your product and your timeline, and stays technical.
