FDA-Compliant Promotional Materials, Guaranteed
Automated compliance checking against FDA OPDP regulations, PhRMA code, and industry standards. Eliminate compliance risk and pass regulatory review with confidence.
The Cost of Non-Compliance
Common FDA OPDP Violations
- • Overstating efficacy or minimizing risks
- • Inadequate fair balance between benefits and risks
- • Insufficient claim substantiation
- • Missing or incomplete safety information
- • Improper use of comparative claims
- • Promotion of off-label uses
How PromoPack Ensures FDA Compliance
Automated OPDP Regulation Checking
Every document is automatically validated against current FDA Office of Prescription Drug Promotion (OPDP) guidelines. Our AI identifies potential violations before they reach regulatory review.
Fair Balance Verification
Automated analysis ensures benefits and risks are presented with appropriate prominence and balance.
Claim Substantiation
Every product claim is matched to peer-reviewed references with adequate statistical support.
Safety Information
Validates inclusion of required safety disclosures and contraindications.
Indication Accuracy
Ensures promotional content stays within approved indications and doesn't imply off-label use.
Complete Audit Trail Documentation
Maintain comprehensive audit trails for every promotional material. Track all reviews, approvals, and modifications with timestamped documentation for regulatory submissions.
PhRMA Code & Industry Standards
Beyond FDA requirements, validate compliance with PhRMA Code on Interactions with Health Care Professionals and other industry self-regulatory standards.
Compliance Features
Eliminate Compliance Risk Today
Try PromoPack's automated FDA compliance checking on your promotional materials
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