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Company Overview

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.

A significant part of our work is with founders and leadership teams who come from outside clinical or regulatory backgrounds — technology, business, design, or consumer wellness. They understand their product and their market. What they need is someone who understands the regulatory environment well enough to translate it into decisions they can act on. That’s what we do.

We work with a small number of clients at any one time. That’s deliberate. It means every engagement gets the same level of attention, rigour, and accountability — from day one through to delivery.

FOUNDER PROFILE

Mona - Founder & Principal Consultant

Mona is a GPhC-registered pharmacist and clinical safety specialist with extensive experience across pharmaceutical practice, digital health, and medical device regulation. She founded Kapinga to give healthtech companies, wellness businesses, and regulated health services direct access to senior clinical and regulatory expertise, without the delays, cost, or distance of a traditional consultancy model. Her credentials span GPhC-registered pharmacy practice, DCB0129 and DCB0160 clinical safety, and EU MDR 2017/745 medical device regulation. She has led clinical safety programmes for NHS digital initiatives, defined regulatory pathways for pre-seed medical device startups, supported wellness platforms navigating the boundary between lifestyle and regulated medical services, and built pharmacy governance frameworks for regulated online services operating across the UK and internationally. Kapinga operates as a specialist team, bringing together senior expertise across clinical safety, medical device regulation, international regulatory compliance, and data governance, covering frameworks including EU MDR, UK MDR, FDA, ISO 13485, and UK GDPR across multiple jurisdictions. A significant part of the work is with founders who have deep expertise in technology, design, or business, but who are entering regulated health for the first time. Kapinga bridges that gap: translating clinical and regulatory requirements into language and decisions that non-clinical teams can act on, without losing the rigour that regulated environments demand. There is no junior team. No account management layer. When you work with Kapinga, you work with specialists.

WORKING PRINCIPLES

Working Principles

01 Patient Safety Over Everything

Every decision starts here. Clinical standards do not flex under commercial pressure. If something carries risk, we say so — clearly and early.

02 Clarity Before Speed

We take the time to understand the full picture before advising. Clear recommendations, communicated directly. No ambiguity, no jargon.

03 Designed for Reality

Governance frameworks that can’t be implemented don’t protect anyone.
We build processes that work in the way organisations actually operate, not the way they ought to in theory.

04 Ownership and Accountability

We take full ownership of our work. Risks get flagged. Issues get escalated. We don’t wait to be asked.

05 High Standards, Without Exception

The standard we hold ourselves to doesn’t vary by client size, sector, or budget. Every engagement gets the same rigour.

GLOBAL REACH

Global Reach

Kapinga has delivered engagements across the United Kingdom, European Union, United States, and United Arab Emirates — across NHS organisations, venture-backed healthtech startups, pharmaceutical services, and medical device companies at every stage of development.

We work remotely and on-site, across time zones and regulatory jurisdictions.