Label Compliance Header Temp

AI-Assisted Label
Compliance WORKFLOW

Label compliance market-ready, faster

Teams can resolve issues earlier, keep decisions traceable, and move labels toward market without fragmented reviews across files, spreadsheets, and email.

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THE CHALLENGE

Label errors become costly downstream

Every market brings different labeling requirements, reviews, approvals, and stakeholders. When compliance issues are caught late, they can lead to rework, scrapped packaging, and launch delays.

Reviewing compliance earlier, before artwork reaches production, gives teams more time to identify and resolve issues.

45.5%

of recalls are attributed to label errors

83.9%

of label-related recalls are due to undeclared allergens

$10M

average direct cost per recall event, excluding brand damage and lost sales

*Loftware analysis of FDA Enforcement Report Database data, 2024. Cost per recall from a GMA and Food Marketing Institute study.

END-TO-END COMPLIANCE REVIEW

Review compliance, in one governed workflow, from product content sheet through label

Check requirements earlier, collaborate throughout the review, and keep the compliance record connected as content moves into packaging.

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01

Set up your label compliance project

Select the target market and product category to define the regulatory context for your review.

02

Add your content. Let AI run the review.

Add your label content or artwork directly to the Content Sheet, import it from a CSV, or upload and annotate your packaging artwork. Then run Label Compliance with RegGenius, our governed AI workspace.

Label Compliance 02
Label Compliance 03

03

AI maps requirements and surfaces findings

RegGenius maps and evaluates the submitted content against applicable requirements for the selected market, surfacing findings that may need to be addressed.

04

Investigate findings and collaborate

Dive deeper into individual findings with RegGenius. Add remarks, collaborate with project members, and update the resolution status as issues are addressed.

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Label Compliance 05 1

05

Keep every action connected

Collaborate through project discussions, assign follow-up tasks, and use the audit log to track changes and activity throughout the project.

GOVERNED COLLABORATION

Bring the whole review into one governed workflow

Review, clarify, assign, and resolve findings with your stakeholders in one place.
Regulatory sources, remarks, actions, approvals, and project history stay connected throughout the review.

Shared Reference 02

Shared references

Supporting sources stay with each finding

Clear Ownership 02

Clear ownership

Route follow-up actions to the right owner

Logged Action 03

Logged actions

Keep remarks and resolutions on record

Audit Trail 01

Audit trail

Maintain a traceable history of the review

“Our agentic workflow connects requirements, findings, team collaboration, and auditability in one place, so teams can move products across global markets with a complete, traceable record of every compliance decision.”

Rohit Gulati | Senior Vice President of Product and Technology, RegASK

PROVEN IN PRACTICE

Faster compliance review,
with control at every step

Reduce review time

Move from days of manual review to minutes per report for early adopters.

Catch issues earlier

Identify missing requirements and compliance gaps before artwork reaches production.

Increase first-time-right

Resolve issues earlier and reduce downstream review and rework.

Maintain traceability

Keep findings, regulatory sources, actions, and approvals connected.

Keep teams aligned

Give regulatory, quality, marketing, and packaging teams one workflow for review and resolution.

Connect to packaging systems

Pass reviewed information into the systems used for artwork and packaging execution.

BUILT FOR REGULATED TEAMS

Compliance review across complex product categories

Check product and label content against market-specific requirements, with regulatory expertise available where judgement is required.

For food and beverage, RegASK reviews label content against the requirements of 19 markets across Asia Pacific, Europe, and the Americas. Selling into one market or ten, each label gets checked against the rules that apply to it.

Frequently asked questions

Getting started with RegASK begins with understanding your regulatory needs, existing processes, and systems. Our team will work with you to identify the right use cases, configure RegASK around your workflows, and support onboarding so your teams can start using the platform effectively. Ready to get started? Book a personalized demo with our team.

RegASK reviews product content sheets and label content against applicable market-specific regulatory requirements. Checks can include nutrition information, ingredient lists and allergen declarations, marketing and soft claims, misleading visuals, front-of-pack labeling, font size requirements, mandatory label elements, and consistency across languages and label content. Findings are prioritized by risk and supported with relevant regulatory citations, so teams can quickly understand what needs attention and why.

Yes. RegASK can integrate with existing enterprise systems through APIs, allowing regulatory intelligence, compliance findings, and workflow data to connect with the tools your teams already use. This supports more connected regulatory workflows while maintaining governance, traceability, and control.

RegASK uses specialized AI agents to review uploaded label artwork in parallel, checking product information, ingredients, claims, artwork, layout, and other label elements against applicable regulatory requirements. It then consolidates the findings into a compliance report, highlighting issues that require attention.

Early adopters have reduced multi-day manual reviews to less than five minutes per report using RegASK’s AI-assisted label review functionality.

Yes. Findings remain connected to their regulatory sources, project history, actions, and resolutions throughout the review.

AI handles the compliance check. Your team reviews and resolves findings. When local knowledge is needed, RegASK’s community of 1,800+ regulatory experts is available for providing in-depth judgement.

Get label content market-ready, faster

Discover how RegASK brings compliance checks, regulatory sources, team collaboration, and human validation into one governed workflow.