Conducted a CMMC Level 2 gap assessment and entity separation analysis for a pharma services distributor sharing physical facilities and IT networks with its parent company. Identified where inherited controls imported gaps rather than satisfying them, delivered warehouse security recommendations, and mapped parallel remediation steps to protect over $5M in annual federal contract revenue and ensure regulatory independence under the DSCSA.

Client: Global Pharmaceutical and Digital Health Organization

Solution: We designed, validated, and deployed a Digital QMS for EHR-integrated pharmaceutical systems. The project unified software validation, cybersecurity, and compliance management under one framework, embedding Zero Trust and privacy-by-design controls across clinical and manufacturing data flows.

Client: A global digital health and personalized wellness company

Solution: We led a privacy and cybersecurity modernization initiative to align healthcare operations with HIPAA and future regulations. We reviewed infrastructure, APIs, encryption, data flows, access control, breach response procedures, and vendor BAAs as well as delivered policies, training and a compliance maintenance plan.

Client: Global medical device manufacturer

Solution: We designed and implemented a unified Premarket Cybersecurity and Data Privacy Program connecting engineering, quality, and security operations. The engagement leveraged our trust assurance framework to automate traceability, documentation, and compliance reporting across U.S., U.K., and EU markets.

Led a comprehensive CMMC Level 2 gap assessment for a multi-entity defense sales and distribution group. Evaluated IT network boundaries, federal contract CUI flows, and physical security at the primary distribution facility. Delivered a 110-control scorecard, identified a baseline SPRS score of -106, and planned a remediation program to protect over $15M in annual federal contract revenue.

Client: Global Pharmaceutical Company

Solution: We implemented a blockchain-anchored data verification layer within the client’s development infrastructure to enhance data authenticity and transparency. The lightweight system created tamper-proof, time-stamped records that could be independently verified without exposing proprietary data.

Client: A global leader in pharmaceuticals and digital health innovation with over 50K employees

Solution: We provided strategy, validation, and regulatory alignment support throughout the development, validation, and deployment of the QMS. The QMS became the single source of truth for all SaMD quality processes, unifying product design, validation, and postmarket operations across the enterprise.

Client: Global Medical Technology Manufacturer

Solution: We conducted a comprehensive regulatory and privacy assessment covering medical device classification, HIPAA compliance, and U.S. state privacy laws. The engagement combined technical, legal, and operational perspectives to deliver an actionable modernization plan.

Developed a CMMC Level 2 readiness roadmap and clean-sheet infrastructure design for a pre-federal R&D and commercialization subsidiary planning its entry into DoD contracting. Delivered a detailed retrofit-vs-clean-sheet cost analysis and sequenced the compliance build behind the parent entity's active remediation to minimize marginal costs.

Client: Daily Foods, a mid-sized global food and beverage manufacturer

Solution: We delivered the first unified SIEM/XDR system for OT in South America and modernized the manufacturer’s cybersecurity program. The result was an immediately measurable reduction in risk as well as downtime and a scalable foundation for ongoing security governance.

Client: Developer of adhesive-based medical identification and connected health technologies

Solution: We designed a Postmarket Cybersecurity Risk Assessment Program that integrated privacy, safety, and security principles into the client’s existing quality management and engineering systems.

Client: A global precision health and genomics company

Solution: We performed a comprehensive HIPAA and GDPR readiness assessment covering U.S. and EU regulatory frameworks. The review included technical controls, policy documentation, and operational governance, culminating in a set of prioritized actions for leadership and engineering teams.