Short-run folding cartons for regulated industries
Digitally printed, cut, and documented in Rogersville, Tennessee for pharmaceutical, medical device, diagnostic, and nutraceutical companies. Cartons from 50 units and IFUs from 1,000.
- FDA-registered facility
- cGMP compliant
- Established 1997
Why short-run digital costs less for small orders
Offset carton plants are built for long runs. Every job pays for plates, steel-rule dies, and hours of make-ready before the first good sheet. Our process skips most of that.
No printing plates
Artwork goes from your approved file straight to a production digital press, so a run of 500 doesn't pay for press setup.
No die to buy for short runs
Short runs are cut and creased on a digital flatbed cutter driven by your dieline file. A new structure doesn't mean a new steel-rule die.
Change artwork anytime
Revise copy, add a language, or update a regulatory line between runs without scrapping inventory or remaking plates.
Cartons, IFUs, and inserts from one supplier
Most regulated products ship with a carton and an insert. We print and finish both under one roof, under one quality system, with matched lot documentation.
- Digital printing, variable-data capable
- Custom die cutting with tight tolerances for miniature formats
- Reverse tuck, straight tuck, lock bottom, sleeves, and inserts
- IFUs: multi-panel, fan-fold, booklet, and miniature folded outserts
- Structural design and dielines when you don't have one
Every regulated order ships with full documentation
No requests required. The documentation package travels with your cartons.
Certificate of Conformance
A signed declaration that the order meets every specified requirement.
Batch record with lot traceability
The production record for the run: lot number, materials, and process data.
Inspection report
Dimensional and visual inspection results against your approved artwork and specifications.
Artwork revision log
A version-controlled record of every artwork approval and revision on the order.
Supplier audits and quality agreements are welcome. See our compliance and quality controls.
Built for regulated product companies
Pharmaceutical
Cartons and inserts for clinical lots, launches, and line extensions, produced to support your 21 CFR Part 211 packaging and labeling controls.
Medical device
Secondary cartons, IFUs, and kit components with revision-controlled artwork and documented count control.
Diagnostics
Precise small-format cartons and inserts for test kits and reagent packaging.
Nutraceutical
cGMP-compliant cartons and labeling components for supplements and wellness products.
More on the industries we serve, including second-source supply
How an order works
One point of contact from first email to delivery.
Send your specs
Dimensions, quantity, and artwork, or a sample carton. A dieline helps but isn't required.
Get a quote
Pricing and a ship date within one business day.
Approve the proof
A PDF proof, plus a physical sample when the structure is new.
We produce and ship
Printed, cut, inspected, counted, and shipped with your documentation package.
Ready to spec your next run?
Cartons from 50 units, IFUs from 1,000. Quotes within one business day.