Industries Served
Regulated product companies rely on us for compliant short-run packaging. We understand the documentation requirements, production standards, and turnaround pressures specific to each sector.
Pharmaceutical
Compliance Documentation
- 21 CFR Part 211 compliant production
- Batch records with lot traceability
- Certificate of Conformance
- FDA-registered facility
Prescription and OTC drug packaging demands strict adherence to current Good Manufacturing Practice regulations. We produce folding cartons and IFUs that meet 21 CFR Part 211 requirements, with full batch records, lot traceability, and Certificates of Conformance on every order.
Common Applications
Medical Device
Compliance Documentation
- ISO 11607 compatible formats
- 21 CFR Part 820 QSR alignment
- Artwork revision log on every order
- Inspection report included
Medical device packaging must maintain sterile barrier integrity and meet labeling requirements under 21 CFR Part 820 and ISO 11607. We produce precision cartons and IFUs for Class I, II, and III device manufacturers.
Common Applications
Nutraceutical
Compliance Documentation
- 21 CFR Part 111 cGMP production
- Certificate of Conformance
- Batch records on every run
- Artwork version control
Dietary supplement and nutraceutical manufacturers face increasing regulatory scrutiny. Our cGMP-compliant production and documentation practices support your quality system and help demonstrate compliance to auditors and retail partners.
Common Applications
Diagnostics
Compliance Documentation
- Tight-tolerance small-format production
- Multi-language IFU capability
- Full inspection report
- Lot traceability documentation
In vitro diagnostic kits require precise small-format packaging with accurate IFU inserts. We specialize in tight-tolerance die cutting and miniature folding for diagnostic kit cartons, with full compliance documentation to support your technical file.
Common Applications
Need packaging for a regulated product?
50-unit carton minimums. Full compliance documentation. 10-working-day standard turnaround.
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