Approve OTC Drug Documentation Faster
Upload your formulations, monograph conformity reports, stability data, supplier certificates, and GMP SOPs and Signify instantly checks every ingredient level, batch record, testing result, and sign-off against 21 CFR Parts 210 and 211, OTC monograph requirements, and major-retailer standards, flagging gaps before your dossier goes to regulators or buyers.
Validate OTC Drugs Safety and Quality Docs. Ensure Readiness.
Launch reformulations and line extensions on schedule while protecting patients and your brand. Signify reviews every formulation record, stability study, batch log, and supplier certificate in seconds, catching gaps and outdated data before submissions reach regulators or retail buyers.
Validate OTC Drugs Safety and Quality Docs. Ensure Readiness.
Launch reformulations and line extensions on schedule while protecting patients and your brand. Signify reviews every formulation record, stability study, batch log, and supplier certificate in seconds, catching gaps and outdated data before submissions reach regulators or retail buyers.
Validate OTC Drugs Safety and Quality Docs. Ensure Readiness.
Launch reformulations and line extensions on schedule while protecting patients and your brand. Signify reviews every formulation record, stability study, batch log, and supplier certificate in seconds, catching gaps and outdated data before submissions reach regulators or retail buyers.
Instant OTC Rule Check
Instant OTC Rule Check
Upload your OTC formulation reports, stability studies, batch records, and monograph references, and Signify instantly scans every active-ingredient concentration, assay result, specification limit, and verifier signature against 21 CFR Parts 210/211, current OTC monograph rules, and retailer documentation standards—flagging any omissions or non-conformities so your submission clears review and reaches shelves on schedule.
Upload your OTC formulation reports, stability studies, batch records, and monograph references, and Signify instantly scans every active-ingredient concentration, assay result, specification limit, and verifier signature against 21 CFR Parts 210/211, current OTC monograph rules, and retailer documentation standards—flagging any omissions or non-conformities so your submission clears review and reaches shelves on schedule.
Upload your OTC formulation reports, stability studies, batch records, and monograph references, and Signify instantly scans every active-ingredient concentration, assay result, specification limit, and verifier signature against 21 CFR Parts 210/211, current OTC monograph rules, and retailer documentation standards—flagging any omissions or non-conformities so your submission clears review and reaches shelves on schedule.
Detailed Compliance Checks
Detailed Compliance Checks
Smart agents continuously analyze every formulation sheet, batch record, stability study, and supplier certificate from draft through final sign-off, verifying ingredient strengths, impurity limits, test dates, and required approvals against 21 CFR Parts 210 and 211, the current OTC monograph, and major-retailer documentation specs. They alert your team to any gaps or expired data in real time, ensuring dossiers pass audits on the first attempt and production stays on schedule.
Smart agents continuously analyze every formulation sheet, batch record, stability study, and supplier certificate from draft through final sign-off, verifying ingredient strengths, impurity limits, test dates, and required approvals against 21 CFR Parts 210 and 211, the current OTC monograph, and major-retailer documentation specs. They alert your team to any gaps or expired data in real time, ensuring dossiers pass audits on the first attempt and production stays on schedule.
Smart agents continuously analyze every formulation sheet, batch record, stability study, and supplier certificate from draft through final sign-off, verifying ingredient strengths, impurity limits, test dates, and required approvals against 21 CFR Parts 210 and 211, the current OTC monograph, and major-retailer documentation specs. They alert your team to any gaps or expired data in real time, ensuring dossiers pass audits on the first attempt and production stays on schedule.
Rapid, No-Friction Approvals
Rapid, No-Friction Approvals
Generate a complete evidence pack with version-tracked batch records, stability data, certificates of analysis, and digital sign-offs for QA teams, regulators, and retailer portals. Deliver audit-ready proof that every OTC dossier meets FDA CGMP, monograph, and retailer standards, accelerating approvals and preventing costly production delays.
Generate a complete evidence pack with version-tracked batch records, stability data, certificates of analysis, and digital sign-offs for QA teams, regulators, and retailer portals. Deliver audit-ready proof that every OTC dossier meets FDA CGMP, monograph, and retailer standards, accelerating approvals and preventing costly production delays.
Generate a complete evidence pack with version-tracked batch records, stability data, certificates of analysis, and digital sign-offs for QA teams, regulators, and retailer portals. Deliver audit-ready proof that every OTC dossier meets FDA CGMP, monograph, and retailer standards, accelerating approvals and preventing costly production delays.
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
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.