Senior clinical and regulatory expertise across five disciplines. We work with healthtech companies, wellness businesses entering regulated services, online pharmacies, and founders from non-clinical backgrounds who need someone to translate the regulatory environment into clear, actionable decisions. No generalists. No junior teams. Work delivered directly by Kapinga.
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 — and remain useful as your product develops.
– 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 and your market. We provide clear EU MDR 2017/745 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
– 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 or not. 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
In regulated health and wellness, how you market your product is as scrutinised as the product itself. We review websites, marketing materials, and digital platforms against MHRA, ASA/CAP Code, GPhC, and CQC standards — identifying non-compliant claims, misleading positioning, and regulatory risk before they become enforcement issues. We also assess clinical and operational pathways against regulatory requirements — reviewing prescribing questionnaires, patient journeys, and system workflows to identify gaps, inconsistencies, and risks that could expose your service to regulatory action or patient harm.
– 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
