Regulatory Excellence
Compliance and validation for regulated software and AI across EU and US markets—covering risk assessment, documentation, verification, audit evidence, accessibility, and ongoing governance.
Compliance by Needs
Choose the track that fits product and market—EU entry, US frameworks, or ISO-based readiness—covering risk, documentation, validation evidence, and accessibility.
EU Compliance
Market entry for EU digital products: risk assessment, technical documentation, conformity workflows aligned with EU expectations.
US Compliance
Alignment with US federal and state expectations: privacy and security controls, accessibility conformance, and audit-ready documentation.
Standards-driven foundation: policy set, risk register, control mapping, SOPs, internal audit and CAPA—to reach certification-ready maturity.
EU AI Act
Risk & Governance
Readiness for the EU’s risk-based AI framework: feature inventory and risk-tiering, role mapping, conformity route, technical file (data, testing, oversight), and post-market monitoring.
Unlock the GDPR Compliance
Operational privacy alignment for EU markets: data mapping and RoPA, lawful-basis design, clear notices and consent flows, rights handling (access/erasure/portability), DPIA and security controls, vendor oversight and cross-border transfer mechanisms, plus incident and retention workflows—with audit-ready documentation.
EMA Annex 11
EU Life Sciences: Computerised Systems
Validation dossier: risk assessment, end-to-end traceability, and IQ/OQ/PQ aligned with Annex 11.
Operational controls: SOPs and records for access management, audit-trail review, change/configuration, and continuity testing.
Ongoing compliance: Periodic evaluation templates, data-integrity checks, training evidence, and inspection pack.
EU Accessibility for Digital Products
Alignment with EU accessibility requirements for software, web, and digital services—WCAG-driven patterns, assistive-technology support, measurable conformance evidence, and a practical remediation roadmap.
Market & Risk
Enables pan-EU market access and public-procurement eligibility, reduces legal and remediation exposure, and provides clear conformance evidence for stakeholders.
User & Product
Enables inclusive UX that increases conversion and retention, with built-in keyboard, screen-reader, and low-vision support, plus reusable patterns that reduce future rework.
Colorado AI Governance & Transparency (CAIA Readiness)
Readiness for Colorado’s AI requirements: identify high-risk uses, map developer vs. deployer duties, establish an NIST-aligned risk-management program, complete impact assessments, implement consumer notices and appeal workflows, and set up incident logging, vendor oversight, and records.
FDA 21 CFR Part 11
US Electronic Records & Signatures
Risk-based validation for GxP systems that handle electronic records and e-signatures. Scope includes system inventory and requirements, security and access control, audit-trail and time-stamp review, e-signature linking, change/configuration management, vendor oversight, SOP set, periodic evaluation, and inspection-ready documentation.
GxP
Computerized System Validation
Risk-based validation for regulated software—clear plan, documented testing, secure records, change controls, and regular quality reviews.
Quality & Data Integrity
End-to-end traceability links requirements to tests and releases.
Operational Readiness
Documentation is inspection-ready using standard templates with periodic review.
ADA Title III WCAG
US Digital Accessibility
Accessibility alignment for websites, apps, and kiosks under U.S. public-accommodations rules—WCAG-based audits, remediation patterns, assistive-technology testing, conformance statements, and ongoing monitoring.
Market & Risk
Pan-US eligibility for enterprise/public procurement with clearer conformance evidence.
User & Product
Inclusive UX that improves task completion, conversion, and retention.
Start Regulatory Readiness
Kick off a fast gap review for your product—prioritized actions, required artifacts, and effort/timeline toward audit-ready validation and governance.