FDA-Compliant Adverse Event Reporting
Made Simple

White-label, embeddable adverse event reporting forms with enterprise-grade audit trails. FDA 21 CFR Part 11 and HIPAA compliant with immutable logging and cryptographic integrity.

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Everything You Need for Compliance

FDA Form 3500/3500A

Pre-configured MedWatch forms matching official FDA templates. Automatically selects correct form based on product type.

MOCRA 15-Day Deadline Tracking

Automatic business day calculation excluding weekends and federal holidays. Dashboard alerts for upcoming deadlines.

Product Label Photos Required

Camera capture and upload support. Auto-compression and secure cloud storage. Required for cosmetics per MOCRA.

White-Label Branding

Custom logo, colors, and domain. Embed form on your website with your brand identity. No "Powered by" watermarks.

Mobile-Optimized Forms

Responsive design works perfectly on phones, tablets, and desktop. Native date/time pickers and camera integration.

FDA 21 CFR Part 11 Audit Trail

Immutable, tamper-evident audit logs with cryptographic hash chaining. Full compliance with FDA and HIPAA requirements for electronic records.

Enterprise-Grade Compliance & Security

Built for regulated industries with the most stringent requirements for data integrity, audit trails, and security.

FDA 21 CFR Part 11 Compliant

Full compliance with FDA regulations for electronic records and signatures

Immutable audit trail - All actions logged with cryptographic hash chaining
Tamper-evident records - Detect any unauthorized changes to historical data
Complete audit trail - Track who did what, when, and from where
User authentication - Multi-factor authentication (MFA) with trusted device management

HIPAA Compliant

Protect patient health information with enterprise-grade security

PHI/PII access logging - Every view, edit, and export of patient data is recorded
6-year data retention - Automatic compliance with FDA record-keeping requirements
Role-based access control - Organization-scoped data isolation with granular permissions
Encrypted data at rest - AES-256 encryption for all stored data and files

Comprehensive Audit Trail Features

Hash Chaining

Each audit log entry is cryptographically linked to the previous entry, creating an immutable chain of evidence

Searchable & Filterable

Advanced search and filtering by user, event type, date range, and resource to find exactly what you need

Event Categories

Authentication, data access, modifications, security events, and system changes - all tracked automatically

How It Works

Sign Up

Create your account and first brand in 2 minutes. No credit card required for trial.

Customize

Add your logo, set your brand colors, and configure form requirements.

Embed

Copy one line of code and paste it into your website. Works with any platform.

Monitor

Track submissions, manage deadlines, and export reports from your dashboard.

Simple, Transparent Pricing

Choose the plan that fits your organization. All plans include 14-day free trial, no credit card required.

Starter

$99/month

Perfect for small businesses and single-brand companies

1 brand embed
Up to 50 reports/month
Basic branding (logo & colors)
Email support
6-year data retention
Full audit trail & compliance

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Professional

$299/month

For growing brands with multiple product lines

Up to 5 brand embeds
Up to 500 reports/month
Custom domain support
Webhook integrations
Priority email support
Bulk export (CSV/XML)
Full audit trail & compliance