SANCIAN advises federal and international leaders on science policy design — aligning emerging technologies with public interest mandates, and supporting compliance with NIST AI RMF, ISO/IEC 42001, WHO ethics guidance, and adjacent standards across FDA, HHS, and global regulatory bodies.
This practice area advises federal science leaders on the policy design and regulatory infrastructure that makes AI adoption defensible — from FDA oversight of AI-enabled medical products through HHS-wide governance frameworks through international standards-body engagement.
SANCIAN's work in this domain is grounded in a specific conviction: that regulatory science is not a downstream compliance function but an upstream design constraint. Frameworks, standards, and policy language get drafted before models get built — not after.
Every engagement is scoped, priced, and delivered against these standard deliverables. Custom scope available on request.
Draft regulatory language, evaluation standards, and oversight mechanisms for federal agencies regulating AI-enabled products and services.
Policy architecture that aligns emerging technologies with public interest mandates — legislative drafting support, agency guidance development, stakeholder analysis.
Compliance and risk assessment support for federal agencies overseeing AI-enabled medical products, health technologies, and clinical decision-support systems.
Advisory on WHO AI ethics guidance, ISO/IEC 42001, and cross-jurisdictional harmonization for federal agencies operating internationally.
Quantitative and qualitative analysis of proposed regulations — cost estimation, equity impact, stakeholder mapping, phased implementation planning.
Development of evaluation standards for safety, efficacy, and quality of AI-enabled health technologies — aligned to federal review pipelines.
Each engagement is anchored in named methodologies with documented standards alignment — the artifacts required for federal review, produced by design.
Advisory grounded in current FDA guidance on AI-enabled medical products — SaMD frameworks, PCCP (predetermined change control), and continuous monitoring protocols.
Consistent with HHS long-term strategic direction on AI adoption, health equity, and mission-aligned innovation.
Harmonization support for federal agencies coordinating with international counterparts — cross-jurisdictional gap analysis, standards mapping.
The full SANCIAN™ Framework applies here — but with particular emphasis on Phase 01 Govern and Phase 04 Design, where regulatory language is drafted.
Representative engagement patterns for federal agencies and international institutions. Actual scope, duration, and pricing determined per engagement.
Advisory on AI-enabled Software as a Medical Device oversight frameworks — safety, efficacy, and quality evaluation standards.
Multi-agency AI governance policy development — alignment across CDC, FDA, NIH, and adjacent oversight bodies.
International AI ethics framework contributions and cross-jurisdictional harmonization support.
Every practice engagement runs on one or more of SANCIAN's proprietary frameworks — named, trademarked, tested.
Phases 01 (Govern), 02 (Map), and 04 (Design) apply heavily — regulatory language is drafted at Design.
Equity impact evaluation embedded into every regulatory analysis — not audited in post hoc.
Executive intelligence briefings for federal regulatory leadership — cognitive load reduction, decision support.
Contracting officers may procure under the codes below. Full SANCIAN registration includes 25 NAICS codes — the subset shown here is most relevant to Practice 02.
| 541611 | Administrative Management & Consulting |
| 541618 | Other Management Consulting |
| 541690 | Scientific & Technical Consulting |
| 541720 | Research & Development |
| R408 | Program Management / Support |
| R426 | Support-Professional: Communications |
| R499 | Support-Professional: Other |
Request the Capability Statement, schedule a briefing with Dr. Crawford, or reach the Government Business POC directly. SANCIAN responds to federal and institutional inquiries within one business day.
