io.github.OrchestraPrime/orchestraprime

Analyze software against FDA Clinical Decision Support (CDS) 4-criteria to determine if it qualifies for the CDS exemption under the 21st Century Cures Act Section 3060. When to use: When you need to assess whether a software product requires FDA clearance/approval or qualifies as exempt CDS. Evaluates all 4 criteria: 1. Not intended to acquire/process medical images or signals 2. Intended to display, analyze, or print medical information 3. Intended for healthcare professionals (not patients) 4. Does not provide specific diagnostic/treatment recommendations Classification: EXEMPT (all 4 met) or DEVICE (any criterion failed)

Analyze a clinical trial protocol against ICH GCP E6(R2) required elements. Checks for presence and completeness of 8 essential protocol sections: background, objectives, design, subjects, treatment, safety, statistical, ethics. When to use: During protocol review to identify missing or incomplete sections before submission. Provides gap analysis with specific recommendations. Overall status: compliant (0 gaps), gaps_found (1-2 gaps), major_gaps (3+)

Get recent regulatory updates and guidance changes from FDA, ICH, EMA, WHO, and CDISC. Shows new guidance documents, rule changes, and announcements. When to use: To check what regulatory changes have happened recently, or to stay current on guidance updates in specific areas. Note: Currently uses curated sample data. Real-time API integration coming soon.

Retrieve the full text, citations, and metadata for a specific regulatory rule. Use rule IDs obtained from search_regulations results. When to use: After finding a relevant rule via search_regulations, use this tool to get the complete rule text, effective dates, and citation information.

List all available sanctions lists with entity counts and coverage details. Includes OFAC SDN, OFAC Consolidated, EU Sanctions, UK HMT, UN Consolidated, and BIS DPL. When to use: To see which sanctions lists are available for screening, or to check entity coverage and last update dates.

List all available regulatory data sources in CTWise, including rule counts and last update timestamps. When to use: To see what regulatory databases are available for searching, or to check how many rules each source contains.

Screen multiple individuals or organizations against global sanctions lists in a single batch operation. Supports up to 100 entities per batch. When to use: For bulk compliance screening during due diligence processes, onboarding multiple counterparties, or periodic re-screening of entity lists. IMPORTANT: Results are NEVER cached and always reflect real-time data. Results should be reviewed by compliance professionals.

Screen an individual or organization against global sanctions lists including OFAC SDN, OFAC Consolidated, EU Sanctions, UK HMT, UN Consolidated, and BIS DPL. When to use: For compliance checks on counterparties, customers, or business partners. Results include match confidence scores and source evidence. IMPORTANT: Results are NEVER cached and always reflect real-time data. Results should be reviewed by compliance professionals.

Search across FDA, ICH, EMA, WHO, and CDISC regulatory databases using natural language. Returns relevant rules with citations, summaries, and reference links. When to use: When you need to find specific regulatory requirements, guidance documents, or rules related to a topic. Supports queries like "What FDA requirements apply to AI diagnostic software?" or "ICH GCP informed consent requirements".