Approve OTC Drug Labels Faster

Upload any OTC label artwork or dieline and Signify instantly checks every Drug Facts panel, active‐ingredient statement, NDC code, warning, claim, and barcode against 21 CFR Part 201.66, OTC Monograph standards, and major-retailer specs before you send files to print.

AI OTC drugs label compliance reviews
AI OTC drugs label compliance reviews

Design Compliant Labels. Safeguard Trust.

Launch reformulations and line extensions on time while protecting patients and your brand. Signify catches costly labeling errors long before products reach the pharmacy shelf.

Design Compliant Labels. Safeguard Trust.

Launch reformulations and line extensions on time while protecting patients and your brand. Signify catches costly labeling errors long before products reach the pharmacy shelf.

Design Compliant Labels. Safeguard Trust.

Launch reformulations and line extensions on time while protecting patients and your brand. Signify catches costly labeling errors long before products reach the pharmacy shelf.

AI OTC drugs label compliance proof
AI OTC drugs label compliance proof
AI OTC drugs label compliance proof

Instant OTC Rule Check

Instant OTC Rule Check

Upload your OTC label artwork and ingredient details, and Signify instantly scans every Drug Facts panel, font size, active and inactive ingredient list, dosage directions, net quantity, NDC code, and mandatory warning against 21 CFR 201.66, OTC monograph rules, and retailer specs—flagging any missing or misplaced elements so your packaging passes review and hits shelves on schedule.

Upload your OTC label artwork and ingredient details, and Signify instantly scans every Drug Facts panel, font size, active and inactive ingredient list, dosage directions, net quantity, NDC code, and mandatory warning against 21 CFR 201.66, OTC monograph rules, and retailer specs—flagging any missing or misplaced elements so your packaging passes review and hits shelves on schedule.

Upload your OTC label artwork and ingredient details, and Signify instantly scans every Drug Facts panel, font size, active and inactive ingredient list, dosage directions, net quantity, NDC code, and mandatory warning against 21 CFR 201.66, OTC monograph rules, and retailer specs—flagging any missing or misplaced elements so your packaging passes review and hits shelves on schedule.

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Detailed Compliance Checks

Detailed Compliance Checks

Smart agents continuously analyze every OTC artwork file from first draft to press-ready PDF, checking Drug Facts layout, active and inactive ingredient order, dosage directions, font sizes, net quantity placement, NDC codes, tamper-evident statements, barcodes, and marketing claims against the latest FDA OTC guidance and retailer specs, then alerting designers to any violation in real time so labels clear review and reach shelves on schedule.

Smart agents continuously analyze every OTC artwork file from first draft to press-ready PDF, checking Drug Facts layout, active and inactive ingredient order, dosage directions, font sizes, net quantity placement, NDC codes, tamper-evident statements, barcodes, and marketing claims against the latest FDA OTC guidance and retailer specs, then alerting designers to any violation in real time so labels clear review and reach shelves on schedule.

Smart agents continuously analyze every OTC artwork file from first draft to press-ready PDF, checking Drug Facts layout, active and inactive ingredient order, dosage directions, font sizes, net quantity placement, NDC codes, tamper-evident statements, barcodes, and marketing claims against the latest FDA OTC guidance and retailer specs, then alerting designers to any violation in real time so labels clear review and reach shelves on schedule.

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AI OTC drugs label compliance checks
AI OTC drugs label compliance checks
AI OTC drugs label compliance checks
AI OTC drugs label compliance review workflow
AI OTC drugs label compliance review workflow
AI OTC drugs label compliance review workflow

Rapid, No-Friction Approvals

Rapid, No-Friction Approvals

Generate a complete evidence pack with annotated OTC artwork, version history, and digital sign-offs for QA teams, regulators, and retailer portals. Deliver audit-ready proof that every label update meets FDA OTC and retailer standards, speeding approvals and preventing costly reprints.

Generate a complete evidence pack with annotated OTC artwork, version history, and digital sign-offs for QA teams, regulators, and retailer portals. Deliver audit-ready proof that every label update meets FDA OTC and retailer standards, speeding approvals and preventing costly reprints.

Generate a complete evidence pack with annotated OTC artwork, version history, and digital sign-offs for QA teams, regulators, and retailer portals. Deliver audit-ready proof that every label update meets FDA OTC and retailer standards, speeding approvals and preventing costly reprints.

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Compliance made easy

AI agents built to help you focus on producing your best work.

Checklists

Create checklists from any requirements document like specs, briefs, brand guidelines, contracts, and more.

Checklists

Create checklists from any requirements document like specs, briefs, brand guidelines, contracts, and more.

Checklists

Create checklists from any requirements document like specs, briefs, brand guidelines, contracts, and more.

Reviews

Validate your work meets every requirement without getting bogged down with review cycles and feedback loops.

Reviews

Validate your work meets every requirement without getting bogged down with review cycles and feedback loops.

Reviews

Validate your work meets every requirement without getting bogged down with review cycles and feedback loops.

Projects

Centralize and organize all critical documents and guidelines in one secure place for easy access and who’s working on them at a glance.

Projects

Centralize and organize all critical documents and guidelines in one secure place for easy access and who’s working on them at a glance.

Projects

Centralize and organize all critical documents and guidelines in one secure place for easy access and who’s working on them at a glance.

Artwork

Annotate design drafts with AI agents to easily understand which requirements you missed and get tips on how to fix them.

Artwork

Annotate design drafts with AI agents to easily understand which requirements you missed and get tips on how to fix them.

Artwork

Annotate design drafts with AI agents to easily understand which requirements you missed and get tips on how to fix them.

Documentation

Review all kinds of documents to ensure edits and changes align with the requirements that matter most.

Documentation

Review all kinds of documents to ensure edits and changes align with the requirements that matter most.

Documentation

Review all kinds of documents to ensure edits and changes align with the requirements that matter most.

AI Agents

Boost your team by adding AI agents that work alongside you, taking care of burdensome tasks while you focus on the important things.

AI Agents

Boost your team by adding AI agents that work alongside you, taking care of burdensome tasks while you focus on the important things.

AI Agents

Boost your team by adding AI agents that work alongside you, taking care of burdensome tasks while you focus on the important things.

Start your free trial

Start your free trial

Start your free trial

Signify AI safety
Signify AI safety
Signify AI safety

World-Class Security

World-Class Security

Keep your data protected with AES-256 encryption, full SOC 2 compliance, and secure infrastructure hosted on Google Cloud and AWS. Customize account permissions and receive real-time security alerts—so your team stays in control, with total peace of mind. Signify never uses your data to train AI models, ensuring your information stays private, protected, and proprietary.

Keep your data protected with AES-256 encryption, full SOC 2 compliance, and secure infrastructure hosted on Google Cloud and AWS. Customize account permissions and receive real-time security alerts—so your team stays in control, with total peace of mind. Signify never uses your data to train AI models, ensuring your information stays private, protected, and proprietary.

Keep your data protected with AES-256 encryption, full SOC 2 compliance, and secure infrastructure hosted on Google Cloud and AWS. Customize account permissions and receive real-time security alerts—so your team stays in control, with total peace of mind. Signify never uses your data to train AI models, ensuring your information stays private, protected, and proprietary.