# Tomato Blue Consulting | RegTech Innovation > Your passport to Compliance and Technology. We navigate GDPR, AI Act, DORA together, transforming regulatory complexity into competitive advantage. - **URL HTML**: https://www.tomato.blue/en - **Versione italiana**: https://www.tomato.blue - **Type**: page - **Language**: en - **Site**: Tomato Blue Consulting — https://www.tomato.blue --- # Don't sink in the perfect Compliance storm **RegTech Innovation** — Navigating risks and regulations requires an integrated approach combining regulatory and technological expertise. - Governance - Risk - Compliance [Free Gap Analysis](https://gap.tomato.blue) · [Contact us](/en/contatti) --- ## The Challenge — Streamline your digital compliance processes We design architectures where technology and compliance are a single supporting structure. eIDAS 2, MiCAR, GDPR, AI Act, DORA, PSD2/3: requirements that become design. ### Regulatory Pressure GDPR, AI Act, DORA: a labyrinth of ever-evolving regulations requiring specialized expertise. ### Human Error Risk Costly manual processes prone to errors that expose the organization to significant risks. ### Critical Consequences Fines up to 4% of turnover, data breaches, and irreversible reputation loss. ### The Technological Regulatory Landscape | Technology | Privacy (GDPR) | Security (NIS 2) | AI Act | MiCAR | |---|---|---|---|---| | Cloud | Data Sovereignty | Supply Chain Risk | — | — | | Gen AI | Portability / Data Subject Rights | Adversarial Attacks | Risk Tiers | — | | Blockchain | Right to Erasure | Network Security | Copyright | Crypto Assets | --- ## Our Competencies at your service Value lies not in individuals, but in organizational functional capability. Total integration between Compliance and Technology. - **Compliance** — Regulatory compliance and thorough Risk Assessment to identify and mitigate risks. - **Standards & CyberSec** — ISO 27001, Audit, and Quality Assurance to ensure the highest security levels. - **Intellectual Property** — Protection of patents, trademarks, design and copyright to safeguard business innovation. - **Privacy** — GDPR compliance, consent management and personal data protection with privacy-by-design approach. - **Infrastructure** — Secure and scalable Cloud architecture designed for resilience. - **Development** — Automation, AI, and API Integration to accelerate innovation. --- ## The Method — Unique Value Cycle A structured approach that transforms regulatory complexity into manageable and measurable processes. ### Phase 1 — Assessment & Decision (Understand if and what to do) **Includes:** Gap analysis · ISMS scope definition · Context and stakeholder analysis · Regulatory and contractual requirements identification. **Key Output:** ISMS Scope · Gap map · Formal kickoff decision. *Typical error: starting from controls.* ### Phase 2 — Governance & Risk (Decide how to manage risk) **Includes:** Risk assessment · Risk treatment · Risk appetite definition · Statement of Applicability (SoA) · Responsibility assignment. **Key Output:** Risk register · Risk treatment plan · Approved SoA. *Management / CISO decides here. Not a technical phase.* ### Phase 3 — Implementation & Operations (Make the system real) **Includes:** Controls implementation (organizational, procedural, technical) · Policy and procedure drafting · Training · Evidence collection · Business process integration. **Key Output:** Operational controls · Verifiable evidence · Functioning ISMS. *ISM + operational functions work here.* ### Phase 4 — Validation & Maintenance (Demonstrate and maintain compliance) **Includes:** Internal audit · Non-conformity management · Management review · Certification audit · Continuous improvement. **Key Output:** Minutes · Corrective actions · Certification · Maintenance plan. *Real maturity is measured here.* --- ## Core Services Specialized solutions for high-tech innovation sectors. - **[RWA Tokenization](/en/servizi/rwa-tokenization)** — Digital representation on blockchain of physical or financial assets such as real estate, shares, credits, gold and artwork. - **[NIS2 Directive Compliance](/en/servizi/nis2)** — New European regulatory framework for cybersecurity and operational resilience for businesses and public entities. - **[CASP Requirements and MiCAR Regulation](/en/servizi/micar)** — Technical and regulatory support for compliance with CASP requirements under the European MiCAR regulation. - **[DPO & CISO as-a-service](/en/servizi/dpo-ciso)** — Data protection and cybersecurity managed by dedicated experts with continuous service. - **[Voluntary NIS 2 Compliance for SMEs](/en/servizi/nis2-pmi)** — Structured voluntary compliance path with NIS 2 Directive for SMEs and startups, with evidence pack for tenders and grants. - **[AI Act Regulatory Compliance](/en/servizi/ai-act)** — AI Act compliance packages calibrated to the organization's size and maturity level. - **[ISO/IEC 27001](/en/servizi/iso-27001)** — Information security management system: measurable, verifiable and defensible risk governance. - **[ISO 9001](/en/servizi/iso-9001)** — Quality management system: structured, measurable and scalable processes for growing organizations. - **[DORA Compliance (EU 2022/2554)](/en/servizi/dora)** — Compliance with EU Regulation 2022/2554 (DORA) for financial services and ICT supply chain: digital operational resilience. ## Target Markets - Fintech & Insuretech - Crypto & Blockchain - MedTech & AI - Industry 4.0 --- ## The Team — Leadership & Expertise A multidisciplinary team combining regulatory, technological, and strategic expertise. - **Massimo Simbula** — Attorney expert in fintech, crypto, AI and privacy. Founder of Studio Legale Simbula, advising startups, VCs, accelerators, banks and public organizations on MiCAR, AI Act, GDPR. DPO for multiple organizations. - **Davide Mula** — Engineer specializing in Information Security. Designs secure architectures integrating cybersecurity and compliance-by-design. Former Professor at LUISS. - **Massimo Caredda** — Attorney in Corporate Law and Data Protection. DPO for public entities and companies. Lecturer in Privacy and Cybersecurity. Former Professor at University of Cagliari. - **Andrea Cocco** — Attorney in Industrial Law and Intellectual Property. Adjunct Professor of Copyright at University of Cagliari, IED and Terni Conservatory. - **Francesco** — Entrepreneur in the software and IT sector. Expert in software architecture and data-driven solutions on cloud, generative AI and complex systems for industrial contexts. - **Manuel** — Entrepreneur in the software and IT sector. Specialized in cloud development, fintech and DevOps, with emphasis on Quality, ISO processes and technical governance. - **Stefano Casu** — Senior manager in digital compliance with a decade of experience applying regulations to business in banking and finance. - **Giovanni Casu** — Expert in blockchain and distributed ledger technologies. Specialized in tokenization, smart contracts and decentralized solutions for the financial sector. --- ## Clients and Partners Our professionals have collaborated with leading financial institutions and internationally renowned organizations: CASD, Chainalysis, CRS4, Intel, Luiss, LVMH, Monetum, Radix, Revolut, Uncommon Digital, United Ventures, Simbula Studio Legale. --- ## Free Gap Analysis Use our Compliance Navigator to receive a preliminary analysis of unmet compliance requirements in your organization. Don't risk penalties — get compliant knowing where to start. - Quick Activation - Implementation Roadmap - No Commitment [Request Gap Analysis](https://gap.tomato.blue) — Immediately useful output for decision making. --- ## Resources for AI agents - Indice sintetico: https://www.tomato.blue/llms.txt - Indice esteso: https://www.tomato.blue/llms-full.txt - Sitemap XML: https://www.tomato.blue/sitemap.xml - Contact: https://www.tomato.blue/en/contatti