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Industry Solution
Pharmaceutical
AI Governance for Drug Marketing, HCP Communications & Patient Education. Maintain FDA fair balance requirements while accelerating content creation.
FDA OPDP Alignment
Fair balance
Quantified risk/benefit assessment
Claim substantiation
Clinical reference verification
Indication boundaries
On-label verification
Material facts
Completeness checking
Misleading presentation
Accuracy evaluation
Critical Use Cases
HCP Communications
Risks
- • Off-label promotion
- • Missing fair balance
- • Unsupported efficacy claims
- • Inadequate safety disclosures
Protection
Indication boundaries, fair balance adequacy, claim substantiation, safety disclosure completeness
Patient Education Materials
Risks
- • Health literacy issues
- • Safety information completeness
- • Promotional content disguised as education
Protection
Health literacy assessment, safety information verification, promotional/educational boundary evaluation
DTC & Social Media Marketing
Risks
- • Fair balance in character limits
- • ISI link requirements
- • Influencer content compliance
Protection
Platform-specific compliance checking, fair balance in constrained formats
Compliance Is Non-Negotiable
A single AI-generated piece crossing indication boundaries can trigger regulatory action affecting your entire portfolio.