About I3CGlobal Organization Structure and Team
We advise and support medical device, IVD, pharmaceutical, food and cosmetic manufacturers worldwide on regulatory documentation, market access and cGMP compliance.
Providing the best regulatory solutions, with quality assurance and data security.
Our core values shape the culture of our organisation and define the character of our company.
Who we are
A firm that advises and supports global healthcare product manufacturers on a wide range of regulatory documentation and cGMP advisory solutions.
Our mission
To understand standard requirements, find new ways and build new strategies that anticipate and overcome questions from regulatory authorities.
Our vision
To emerge as a leading regulatory consulting company through the endorsement of satisfied customers — which we consider our biggest testament.
Practical experience behind every submission.
Our consultants bring hands-on experience from medical device, pharmaceutical, food and cosmetic manufacturing to every project we take on.
“We care deeply about what we do and the impact we have with our clients and with the communities in which we work and live. It is personal to all of us.”The I3CGlobal team
A global regulatory and compliance partner.
I3CGlobal serves multinational, medium-sized and emerging healthcare product manufacturers. Our experienced medical device consultants provide comprehensive regulatory services for EU MDR, IVDR, UKCA and U.S. FDA compliance, helping manufacturers achieve and maintain access to global markets.
Founded in 2000, we have become a trusted partner for companies launching healthcare products in the United States, Europe and other international markets, supporting MDR, IVDR, FDA 510(k), CE Marking, QMSR and ISO 13485 projects worldwide.
A significant portion of our new business comes through referrals from existing clients — a reflection of the trust they place in our work. Read client testimonials →
Five offices, one regulatory team.
Our consultants operate from Germany, India, Portugal, the United Kingdom and the United States, supporting compliance projects worldwide. We also work through associated offices in Malaysia, Vietnam and South Korea.
Dedicated specialists for every regulatory pathway.
Headcount by department — team leads, senior consultants and junior consultants.
| Department | Team leads | Sr. consultants | Jr. consultants | Total |
|---|---|---|---|---|
| FDA 510(k) | 2 | 6 | 13 | 21 |
| MDR Technical Documentation | 2 | 10 | 10 | 23 |
| MDR Clinical Evaluation | 2 | 12 | 16 | 30 |
| IVDR Technical Documentation | – | 3 | 10 | 13 |
| IVDR Performance Evaluation | – | 3 | 8 | 11 |
| Risk Analysis | – | 3 | – | 3 |
| In-Country Registrations (EU-UK-USA) | 1 | 17 | 14 | 32 |
| QMS / GMP / Facility Design | 1 | 7 | 6 | 14 |
| Marketing | 1 | 1 | 2 | 4 |
| Administration & HR | 2 | 1 | 3 | 6 |
The people behind I3CGlobal.
Qualified professionals from the medical device, pharmaceutical, food and cosmetic industries.
Founding team
The founders who established I3CGlobal in 2000 and continue to shape its direction, values and client relationships.
Management team
Our management team blends strategic vision with regulatory compliance expertise, guiding the company with effective leadership, collaboration and adaptability.
Technical associates & mentors
Supporting consultants and writers with analysis, review and troubleshooting, research and regulatory correspondence — and transferring knowledge from senior professionals to junior staff.
Managers
Department managers who lead our US FDA and EU-UK compliance projects.
Team leads
Team leads who drive day-to-day delivery across quality management systems, US FDA submissions, FDA 510(k) and MDR clinical evaluation.
Projects and achievements.
Projects taken on during the year 2024-2026 and those completed, by service area.
Some of Our Clients
Clients who trust us.
Trusted by leading medical device, pharmaceutical, diagnostics and consumer healthcare companies worldwide.
Certified systems, protected data.
Our own management systems are independently certified, so your technical files and data are handled under controlled processes.
Planning a regulatory submission or certification?
Request a tailored quote using the relevant Quote Request Form provided below, or send us a quick enquiry through the contact form on the right side of the screen.