AI-powered checks for
material review, labeling, and safety monitoring.
Automate advertising review for drugs and medical devices, package insert consistency checks, and adverse event triage with documented rationale.
Use existing internal review standards as-is|Supports closed internal networks|Start with one product or one material
Claims Checklist
6 checksThe headline states, "Can be used safely by anyone, with no concern about adverse reactions…
- Applicable rule
- PMD Act Article 66(1)
- Source comparison
- Potential regulatory conflict
- AI confidence
- 93%
- -75%
- Workload for material review
- 95%+
- Assessments with documented rationale
- Same day
- Company-wide rollout of review standards
From intake to sign-off, people review only what matters
AI handles review-point extraction and source citation, while people focus on final checks for items that need attention.
Import existing documents
Load material drafts, package inserts, and safety information directly from PDF or Excel.
AI extracts review points
Automatically identifies checks and required evidence from the PMD Act, advertising standards, and internal rules.
Assess with rationale
Determines compliant, non-compliant, or review-needed status while citing applicable provisions and guidelines.
Humans review and finalize
Regulatory and safety teams confirm only the items needing attention. Results are automatically recorded as review evidence.
Healthcare and pharma checks, shown in realistic screens
See specialized review work for material review, labeling, and safety monitoring through practical use-case screens.
Promotional Material Claims Review
Automatically checks sales materials, product brochures, and web ads against the PMD Act, appropriate advertising standards, and the JPMA Promotion Code. It flags unapproved indications and exaggerated claims with supporting rationale.
Common Challenges
- Regulatory Affairs cannot keep up with reviews for every product's promotional materials
- Claims beyond approved scope and exaggerated wording are easy to miss
- Judgment on unacceptable claims varies by reviewer or branch
Applicable Laws and Standards
Claims Checklist
6 checksThe headline states, "Can be used safely by anyone, with no concern about adverse reactions…
- Applicable rule
- PMD Act Article 66(1)
- Source comparison
- Potential regulatory conflict
- AI confidence
- 93%
Potential unapproved claims and exaggerated statements appear first. Click a row to open the relevant wording and supporting provision in place.
Broad support for healthcare and pharma laws, standards, and internal rules
Bring in the exact yardsticks you use for review, from laws and industry standards to your own internal criteria.
Advertising and promotion
- PMD Act Articles 66 and 68
- Appropriate Advertising Standards for Drugs and Medical Devices
- JPMA Promotion Code
Labeling and package inserts
- Electronic package inserts
- Package Insert Guidance
- Product and packaging labeling
Safety and post-marketing
- GVP Ordinance
- Adverse Drug Reaction Reporting System
- Risk Management Plan (RMP)
Quality and internal rules
- GQP Ordinance
- SOPs and procedures
- Internal promotion rules
Custom support is available for laws and internal standards beyond those listed above. Bring your existing review criteria as-is.
"When review requests for sales materials and product brochures came in all at once, Regulatory Affairs alone could not keep up. Every finding now includes the supporting provision, so explaining returns to requesters is faster and we no longer miss unapproved claims."
Company names are anonymized by industry and scale due to confidentiality obligations. Detailed case studies are available in individual consultations.
Start with one material or package insert and see the impact.
Bring your promotional materials or package inserts and we will demonstrate the actual assessment screen. Closed internal environments and on-premises deployment are also supported.
Trial available as soon as the same day|ISO/IEC 27001-aligned platform