Tailored engagements suited to defined deliverables—such as a CE marking roadmap, DCB0129 hazard workshop, or pharmacy compliance audit.
Senior clinical safety and regulatory expertise across five disciplines, delivered directly by specialists. We work with healthtech companies, online clinics, wellness businesses entering regulated services, and founders from non-clinical backgrounds who need someone to translate complex regulatory requirements into clear, actionable decisions. No generalists. No junior teams. No account management layer.
Clinical safety documentation is a regulatory requirement, not a box-ticking exercise. We build DCB0129 and DCB0160 compliant hazard workshops, clinical safety case reports, and hazard logs that hold up under inspection, structured, auditable, and built to remain useful as your product and regulatory obligations evolve.
– DCB0129 & DCB0160 hazard identification and documentation
– Clinical Safety Case development and sign-off
– Hazard log creation and governance
– AI and algorithm-assisted tool safety reviews
Your regulatory pathway determines your timeline, your market, and your investment story. We provide clear EU MDR 2017/745, UK MDR, and FDA regulatory strategy, from device classification and clinical evaluation through to notified body engagement and CE marking. A defined plan with measurable milestones, not a holding position.
–EU MDR classification and compliance strategy
– Clinical Evaluation Plans and SOTA literature reviews
– Notified body selection and outreach
– AI and algorithm-assisted tool safety reviews
Online prescribing and pharmacy services operate under some of the most demanding regulatory scrutiny in healthcare. We design and implement clinical and operational frameworks that keep your service compliant with GPhC, CQC, and MHRA requirements, built to withstand inspection and function as you scale.
– GPhC, CQC, and MHRA compliance frameworks
– Prescribing and dispensing pathway design
– Clinical questionnaire and SOP development
– Pharmacy service design and workflow optimization
Regulatory complexity stops products and slows teams down. We work with healthtech founders and wellness businesses crossing into regulated services, translating requirements into clear product decisions, regardless of whether the leadership team has a clinical background. If you’re building in this space for the first time, we’ll make sure you understand what’s required, why it matters, and exactly what to do about it.
– Regulatory strategy for healthtech and wellness products at any stage
– Clinical governance frameworks for AI-powered tools
– Investor-facing regulatory and clinical documentation
– Pre-submission regulatory planning and positioning
– Wellness-to-regulated transition support: defining the boundary, managing the shift
– Founder advisory for non-clinical leadership teams entering regulated health
– Website and marketing compliance reviews against MHRA, ASA/CAP Code, and GPhC standards
– Healthcare advertising and claims audits
– Prescribing pathway and clinical questionnaire review
– Patient journey assessment against GPhC, CQC, and MHRA requirements
– System and workflow gap analysis for online pharmacy and digital health platforms
– Written compliance reports with prioritised recommendations
Ongoing senior clinical and regulatory expertise for organisations that need continuous support without a full-time hire.