Sold by: Orchestra Prime
Deployed on AWS
Quick Launch
CTWise Regulatory Rules API delivers instant, programmatic access to FDA CFR Title 21, ICH Guidelines (E6 GCP, E8, E9), EMA regulations, and WHO guidance. Unlike document-based solutions, query specific rule citations in milliseconds via REST API. 500+ regulatory rules covering 21 CFR Part 11, GCP compliance, informed consent, and IRB oversight with semantic search and version tracking. Ideal for pharmaceutical R&D, CROs, and clinical operations teams building compliant protocols. Transparent pricing: Free 14-day trial (1,000 API calls), Starter $99/month (10,000 calls).
Overview
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.
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.
Start your free 14-day trial today and experience the power of automated regulatory compliance.
Highlights
- 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.
Details
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Delivery method
Deployed on AWS
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Leverage AWS CloudFormation templates to reduce the time and resources required to configure, deploy, and launch your software.
Pricing
Pricing is based on the duration and terms of your contract with the vendor, and additional usage. You pay upfront or in installments according to your contract terms with the vendor. This entitles you to a specified quantity of use for the contract duration. Usage-based pricing is in effect for overages or additional usage not covered in the contract. These charges are applied on top of the contract price. If you choose not to renew or replace your contract before the contract end date, access to your entitlements will expire.
Additional AWS infrastructure costs may apply. Use the AWS Pricing Calculator to estimate your infrastructure costs.
Dimension | Description | Cost/month | Overage cost |
|---|---|---|---|
Starter Plan | 10,000 API calls/month for regulatory rules | $99.00 | - |
Pro Plan | 50,000 API calls/month + priority support | $299.00 | - |
API Overage | Additional API calls beyond plan limit | $0.00 |
Dimensions summary
This listing bills by monthly API calls to the regulatory rules service. You choose between two plans based on your expected call volume. The Starter Plan includes 10,000 API calls per month. The Pro Plan includes 50,000 API calls per month and adds priority support. If you exceed your plan's monthly limit, the API Overage dimension charges you for each additional call. This lets you scale usage without switching plans. Together, the plans set your base monthly allowance, and overage covers demand beyond it.
Top-of-mind questions for buyers
One API call is a single request to the regulatory rules service, such as a semantic search or a lookup. Each request you send with your API key counts as one call against your monthly plan allowance, whether it returns one result or many.
Once you pass your plan's included calls, the API Overage dimension charges you per additional call. You keep using the service without switching plans. The overage applies only to calls beyond your monthly allowance, not to all calls.
Your plan sets a fixed monthly base for its included calls. If you stay within that allowance, only the plan charge applies. If you go over, overage charges add on top per extra call. Both appear on the same invoice.
docs.ctwise.ai
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Vendor refund policy
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.
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Vendor terms and conditions
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Content disclaimer
Vendors are responsible for their product descriptions and other product content. AWS does not warrant that vendors' product descriptions or other product content are accurate, complete, reliable, current, or error-free.
Delivery details
Software as a Service (SaaS)
SaaS delivers cloud-based software applications directly to customers over the internet. You can access these applications through a subscription model. You will pay recurring monthly usage fees through your AWS bill, while AWS handles deployment and infrastructure management, ensuring scalability, reliability, and seamless integration with other AWS services.
Additional details
Usage instructions
Manual Configuration (Alternative to Quick Launch)
If you prefer to configure CTWise manually instead of using Quick Launch:
Step 1: Get Your API Key
After subscribing via AWS Marketplace, you have two options to obtain your API key:
Option A: Welcome Email (Automatic)
- After completing registration, you'll receive a welcome email containing your API key
- The API key is shown only once in this email for security
- Copy and store it securely immediately
Option B: Dashboard Generation
- Log in to app.orchestraprime.ai
- Navigate to API Keys in the sidebar
- Click "+ Create New Key"
- Give your key a descriptive name (e.g., "Production Key")
- Click Create Key
- Important: Copy the full API key immediately - it is shown only once and cannot be retrieved later (only the hash is stored)
Your API key starts with ctw_ (e.g., ctw_abc123_xyz789...)
Step 2: Store API Key Securely (Recommended)
Store your API key in AWS Secrets Manager for secure access from your applications:
aws secretsmanager create-secret \ --name ctwise-api-key \ --secret-string "YOUR_API_KEY_HERE" Step 3: Configure Your Application Set these environment variables in your application: Variable Value CTWISE_API_KEY Your API key from Step 1 CTWISE_API_BASE_URL <https://api.ctwise.ai> CTWISE_API_VERSION v1 Step 4: Test the Connection curl -X GET "https://api.ctwise.ai/v1/catalog/sources" \ -H "x-api-key: YOUR_API_KEY" Security Notes API keys are shown only once at creation time - store them securely Only a hash of your key is stored in our system for validation If you lose your key, create a new one and revoke the old key Never commit API keys to version control Documentation Full API Documentation: <https://docs.ctwise.ai> Getting Started Guide: <https://docs.ctwise.ai/getting-started> Support: <support@orchestraprime.ai>Resources
Vendor resources
Support
Vendor support
CTWise Regulatory Rules API is backed by OrchestraPrime's dedicated support team with deep expertise in clinical trial regulations and compliance technology.
SUPPORT CHANNELS:
- Email: support@orchestraprime.ai (Primary support channel)
- Documentation: https://docs.ctwise.ai (Comprehensive API docs, tutorials, and guides)
- Status Page: https://status.orchestraprime.ai (Real-time service health)
RESPONSE TIMES:
- Critical Issues (API Down): 4-hour response, 24/7 monitoring
- High Priority (Functionality Impact): 8-hour response during business hours
- Standard Inquiries: 24-hour response during business hours (Mon-Fri, 9 AM - 6 PM EST)
SUPPORT INCLUDES:
- API integration assistance and best practices guidance
- Regulatory content questions and rule interpretation support
- Account management and billing inquiries
- Feature requests and product feedback
SELF-SERVICE RESOURCES:
- Interactive API documentation with live examples
- Code samples in Python, JavaScript, Java, and .NET
- Troubleshooting guides and FAQ
- Changelog and release notes for API updates
ENTERPRISE SUPPORT (Available for Enterprise tier):
- Dedicated Technical Account Manager
- Custom SLA with guaranteed response times
- Priority feature development
- Quarterly business reviews
OrchestraPrime is committed to helping life sciences organizations accelerate clinical research through regulatory intelligence. Our support team combines technical expertise with regulatory domain knowledge to ensure your success.
AWS infrastructure support
AWS Support is a one-on-one, fast-response support channel that is staffed 24x7x365 with experienced and technical support engineers. The service helps customers of all sizes and technical abilities to successfully utilize the products and features provided by Amazon Web Services.
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