Regulatory Strategy & Compliance Engineering
We help organizations operate with confidence in complex, regulated environments. Whether you’re preparing for an audit, responding to a compliance failure, or scaling a product into new jurisdictions, we provide actionable regulatory strategy and engineering-level rigor.
Our approach blends deep regulatory knowledge with enterprise delivery expertise. From HIPAA and FDA to GDPR and ISO 13485, we align policy, systems, and teams around what matters most: readiness, risk mitigation, and sustainable controls.
RHTP Plan Development for State Health Systems
We help states meet CMS timelines and submit compliant Rural Health Transformation Plans—leveraging FHIR modernization, oversight, and sustainable delivery models.
Core Capabilities
Regulatory Framework Alignment
Map operations and systems to key regulatory frameworks like HIPAA, GDPR, FDA, and ISO 13485.
Audit Preparation & Remediation
Support internal and external audits, address gaps, and respond to findings with structured remediation plans.
Policy & Documentation Strategy
Develop and align IT, clinical, and product policies with enterprise risk and compliance standards.
Vendor & SaaS Compliance Reviews
Evaluate PHI, data access, and contractual compliance risks during procurement, onboarding, or M&A.
Cross-Jurisdictional Compliance Support
Navigate U.S. federal, state, and international regulatory requirements with scalable strategies.
Compliance Engineering for Product & IT Teams
Embed compliance into product workflows, system architecture, and delivery models to reduce friction and future risk.
Case Studies
Trusted by Teams Navigating Complex Compliance
We support healthcare systems, product teams, and public-sector agencies through critical compliance challenges with actionable, real-world strategy. Client names withheld for confidentiality. Full case study portfolio available upon request.
Need Strategic Compliance Without the Guesswork?
From policy development to audit recovery, we help teams navigate regulation with clarity and precision — across healthcare, technology, and manufacturing.