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Warnings, batch fields, IFUs, barcodes, and Braille panels all have something in common: no place for mistakes. Approval Studio brings regulatory, QA, and marketing onto one file, so every detail gets checked, every change gets compared, and every sign-off is recorded.
Pharmaceutical artwork approval is the review and sign-off of every printed component of a medicine or medical device, including labels, cartons, leaflets, and IFUs, before it goes to print. Labeling and packaging issues cause roughly 1 in 5 FDA drug recalls. Approval Studio keeps every reviewer on the same file and every sign-off on record, so errors get caught in review, not in the market.
WITH APPROVAL STUDIO
BEFORE
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Pharma artwork doesn’t get approved by one person, and it shouldn’t get approved by whoever answers the email first either. In Approval Studio, you can set up approval workflows with review groups for each department, run them in sequence or in parallel, and watch the artwork move on only when the group before it has signed off.
In pharma, the scary edit is the one nobody asked for: a warning that disappeared in v3 or a strength that moved on the side flap. View asset versions side by side, toggle, fade, or highlight differences, so your team is not playing “spot the difference” on a pharmaceutical carton.
A barcode that looks fine on screen can still decode to the wrong code or sit too close to a fold. Approval Studio supports 15 types of barcodes. Scan them on the mock-up, check what they read and where they’re placed, and pin a comment if something isn’t right. You can also use our on-screen ruler for precise dimensions.
Increase accountability across your team by assigning reviewers specific areas to verify, such as label accuracy, regulatory compliance, or artwork specifications. Make sure that every review checklist item, be it dosage information or pack design details, is confirmed before approval or rejection is finalized.
Our ABC Reports feature flags anything that doesn’t line up before a human reviewer opens the file. Just upload a regulatory checklist, ISO spec, or brand guideline, and let AI run your file against it. This way, your regulatory team’s first pass just starts with a list of what to look at, skipping right to the important problem-solving part.
Who uses pharmaceutical artwork approval software?
Label change requests show up whenever marketing rebrands a product, a regional office needs a translated variant, or regulatory flags a wording fix. Approval Studio gives each department its own reviewer group, and lets you define exactly how many sign-offs a label needs before it’s locked. Nothing ships on a single rushed approval, and nothing sits waiting on people who were never supposed to review it.
Running artwork for a dozen clients at once means a dozen different specs, approval chains, and print deadlines in the same week. But if you keep each client’s assets, reviewers, and version history separate and traceable, a client’s QA team can sign off on their own artwork directly, and you always know which version was cleared for which production run.
A device sold in ten markets means ten labeling variants, each with its own regulatory quirks and its own risk of the wrong one reaching print. We keep a full version history of what actually shipped to each market, and let distributors or regional partners review their local artwork directly, without having to download or log in.
Every color, claim, and pack panel needs a documented yes from someone with the authority to give it. Approval Studio timestamps every comment and sign-off against the exact file version it was made on, so if a client ever asks “who approved this artwork” months after it shipped, the answer sits in the record instead of buried in an email thread.
Cheaper than missed deadlines and chaotic stressful workflow
per user / month
per user / month
per user / month
CLIENT INTERVIEWS
