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Clinical Safety. Regulatory Clarity.
Delivered.

Kapinga is a founder-led clinical safety and regulatory consultancy. We work directly with healthtech companies, wellness businesses moving into regulated services, and online pharmacy platforms — embedded in your team, focused on what moves things forward. Many of our clients are founders without a clinical or regulatory background. That’s not a problem. It’s exactly where we add the most value.

Our Clients

Trusted by

Core Services

Specialist support across safety, regulation, operations, and digital health.

01 Clinical Safety Governance

We build DCB0129 and DCB0160 compliant clinical safety frameworks for digital health products. Hazard workshops, safety cases, and hazard logs — structured, auditable, ready for regulatory scrutiny.

02 Medical Device Regulatory Strategy

We define your EU MDR regulatory pathway and get you to CE marking. Classification, clinical evaluation, notified body engagement — a clear plan, not a holding position.

03 Pharmacy & Medicines Governance

We design and implement clinical and operational frameworks for online prescribing and pharmacy services. GPhC, CQC, and MHRA compliant — built to function at scale.

04 Digital Health & Wellness Advisory

We translate regulatory complexity into product decisions. Whether you’re raising investment or preparing for market, we give you the clinical and regulatory foundation to move with confidence.

05 Marketing & Systems Compliance

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.

GLOBAL EXPERIENCE

Credibility Metrics

Kapinga has delivered clinical safety and regulatory engagements across the UK,
European Union, United States, and UAE. The same standard of work, regardless of jurisdiction.

13 Years

4 Sectors

International

Concurrent Engagements

TEASERS

Case Studies

01 FemTech Startup

02 Regulated Online Pharmacy

03 Online Pharmacy Audits

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