A selection of engagements across clinical safety, pharmacy governance, and medical device regulation. All anonymised in line with client confidentiality.
A selection of engagements across clinical safety, pharmacy governance, and medical device regulation. All anonymised in line with client confidentiality.
Kapinga led the full regulatory workstream. Device classification was established, the CE marking pathway defined, and a product development task matrix built across eight workstreams with a phased timeline through to submission. Clinical Evaluation planning, SOTA literature review strategy, and notified body outreach were initiated. Critical gaps across hardware engineering, biocompatibility, and quality management were identified and documented, with mitigation strategies built into the development roadmap.
A structured, investor-credible regulatory strategy. Defined CE marking pathway. Notified body engagement underway. Phased development roadmap aligned to EU MDR 2017/745.
A series of distance-selling pharmacies delivering remote prescribing and dispensing services — including higher-risk medications — required independent clinical governance review. Each operated a fully digital patient journey with questionnaire-led prescribing and limited existing oversight frameworks.
Kapinga conducted structured audits across prescribing models, SOPs, and patient pathways against GPhC standards and digital health best practice. Key risks were identified across questionnaire-led supply of higher-risk treatments, prescriber oversight gaps, and documentation quality. Targeted recommendations were delivered to strengthen governance, reduce prescribing risk, and align operations with regulatory expectations.
Clear, actionable governance recommendations across multiple online pharmacy services. Improved clinical safety, prescribing robustness, and regulatory alignment.
A regulated online pharmacy and wellness business expanding into prescription services needed a clinical and operational governance framework built from scratch. Operating across cannabis-based medicinal products, GLP-1, and TRT pathways, the organisation required senior pharmacy expertise embedded across compliance, patient safety, and operational design.
Kapinga led clinical governance across multiple workstreams — patient eligibility frameworks, clinical questionnaire design, prescriber pathway documentation, and KPI infrastructure. Compliance across CQC, GPhC, MHRA, and ASA/CAP Code requirements was assessed and embedded into operational processes. Clinical safety thinking was integrated across the full patient journey, from initial assessment through to dispensing and follow-up.
A fully operational clinical governance structure across prescription pathways. Compliant, auditable, and built to scale.
A femtech platform focused on holistic women’s health was in early-stage product development, combining wellness, education, and digital tools. The team needed senior clinical input to establish clear boundaries between wellness and regulated medical positioning — and to embed clinical safety thinking from the outset.
Kapinga mapped patient journeys and translated regulatory requirements into product decisions, influencing the roadmap directly. Clear positioning boundaries were established between wellness and regulated medical services. User research was supported from a clinical perspective, and a compliant product architecture was defined — enabling the team to build with confidence without compromising on safety or regulatory integrity.
A clinically grounded product roadmap. Clear regulatory positioning. A user-centred design framework built for scale.
