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.
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.
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.