CTWise Regulatory Rules API
Orchestra Prime · Software Development
Certification per AWS Marketplace.
Evidence tier Source Confirmed · 4 captures on record
What the publisher says
As described on AWS Marketplace.
## Overview
CTWise Regulatory Rules API is a comprehensive regulatory intelligence platform designed for clinical trial compliance. Access the latest FDA, ICH, EMA, and WHO guidelines through a modern REST API with sub-second response times.
Show the rest of the publisher’s description (39 more lines)
## Key Features
### Regulatory Coverage
- **FDA CFR Title 21**: Parts 11, 50, 54, 56, 312, 314
- **ICH Guidelines**: E6(R2) GCP, E8 General Considerations, E9 Statistical Principles
- **EMA Regulations**: Clinical trial requirements for EU submissions
- **WHO Guidance**: International clinical trial standards
### API Capabilities
- **Semantic Search**: Find relevant rules using natural language queries
- **Version Control**: Track rule changes with effective dates and revision history
- **Real-time Updates**: Webhook notifications when regulations change
- **Bulk Export**: Download rule sets in JSON, CSV, or Parquet format
### Compliance Features
- **Audit Trail**: Complete logging for GxP compliance
- **SOC2 Ready**: Built on AWS with enterprise security
- **HIPAA Eligible**: Suitable for healthcare data workflows
## Use Cases
- **Protocol Development**: Validate clinical trial protocols against current regulations
- **Regulatory Submissions**: Ensure submission packages meet FDA/EMA requirements
- **Compliance Monitoring**: Track regulatory changes affecting ongoing trials
- **Training & Education**: Build compliance training platforms with authoritative content
## Pricing Tiers
| Tier | Price | API Calls/Month | Rate Limit |
|------|-------|-----------------|------------|
| Free Trial | $0 (14 days) | 1,000 | 2/sec |
| Starter | $99/month | 10,000 | 10/sec |
## Technical Specifications
- **API Type**: REST with JSON responses
- **Authentication**: API Key + JWT
- **Availability**: 99.9% SLA
- **Latency**: <200ms p95
- **Region**: us-east-1 (multi-region available for Enterprise)
## Support
- **Documentation**: https://docs.ctwise.ai
- **Email Support**: support@orchestraprime.ai
- **Response Time**: 24 hours (business days)
## About OrchestraPrime
OrchestraPrime delivers enterprise API products for regulatory compliance and risk management. Our mission is to accelerate clinical research by providing instant access to regulatory intelligence.
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Start your free 14-day trial today and experience the power of automated regulatory compliance.
Highlights
Highlighted by the publisher on AWS Marketplace.
Access FDA CFR Title 21, ICH Guidelines (E6 GCP, E8, E9), EMA regulations, and WHO guidance through a single unified API. Unlike AI document generators, get precise rule citations programmatically. Query 500+ regulatory rules spanning clinical trial requirements, 21 CFR Part 11 data integrity, informed consent, IRB oversight, and GCP compliance. Automatic daily updates ensure current regulatory intelligence.
Query regulatory rules in under 200ms using natural language or specific CFR citations. Our semantic search understands clinical trial terminology and returns precise rule citations with full context - no manual document searching required. Features include fuzzy matching for regulation references, cross-reference linking between related rules, and real-time webhook notifications when regulations change. Integrate in hours, not weeks.
Built for GxP-regulated environments with comprehensive audit trails, SOC2-ready architecture, and HIPAA-eligible infrastructure. Every API call logged with timestamps, user context, and query details for regulatory audits. 99.9% availability SLA with <200ms p95 latency. Transparent pricing: Free 14-day trial (1,000 calls), Starter $99/month (10,000 calls). No hidden fees, no enterprise sales process required.
Agent build and provenance
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Compliance
- FedRAMPConfirmedNot listed90%, registry-checkedNo FedRAMP Marketplace entry matched this vendor's domain, checked 2026-08-27registry recordas observed 2026-08-27
Confirmed means matched to a public authoritative registry. Claimed means the vendor or its listing states it, not yet cross-checked. A framework not shown was not found in any source we hold, which is not evidence against it. Not listed means a scoped registry check found no match for this vendor's domain: a No is a scoped registry check, not a compliance judgment. Confidence bands: 95% domain-verified, 90% registry-checked, 80% self-attested, 70% weak signal. Self-attested items marked “vendor's site” are gathered from the vendor's own website and are not verified by us.
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External enrichment
Plans and pricing as listed
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Refund terms
As stated by the publisher on AWS Marketplace.
No refunds for usage-based charges. API requests are billed based on actual consumption and cannot be reversed once processed. AWS Marketplace provides automatic refunds within 48 hours of initial subscription per AWS policy. For billing disputes or metering errors, contact support@orchestraprime.ai within 30 days. We recommend testing with our free tier before scaling usage.
Sources
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2 linksLinked repositories
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