I3cglobal

What I3cglobal does

I3CGlobal is a Bangalore-headquartered life sciences regulatory consulting firm founded in 2010 that supports medical device, in vitro diagnostic, pharmaceutical, cosmetic, and food/dietary supplement manufacturers in achieving regulatory compliance across the EU, US, and UK. Its core service portfolio covers EU MDR 2017/745 and EU IVDR 2017/746 CE Marking, US FDA 510(k) premarket notification, UKCA Marking, ISO 13485 quality management certification, MDSAP audit support, and FDA QMSR consulting, supplemented by recurring annual EU Authorized Representative (EAR) and UK Responsible Person (UKRP) legal representation services for non-EU/non-UK manufacturers, plus one-time purchase of proprietary Microsoft Word technical file templates, GSPR checklists, and procedure templates.

The company operates an ISO 27001-certified cloud documentation platform with a 24/7 uptime guarantee for secure handling of confidential technical specifications, and delivers services through full-time dedicated regulatory experts organized in teams of 20-25 led by Senior Associates. Its commercial model blends project-based professional services (with publicly listed pricing for templates and select consulting engagements), recurring subscription revenue from annual EAR/UKRP engagements, and one-time license fees for downloadable compliance templates. Go-to-market combines enterprise field sales, inbound content marketing (free gap analysis checklists, blog articles, case studies, and press releases), online proposal request forms, and strategic partnerships with clinical research organizations such as Reghelps SRC CRO and IQZYME Medtech for IVD performance evaluation.

The company maintains seven physical offices across the US (Charlotte), UK (London/Ilford), India (Bangalore), Germany (Mönchengladbach), Portugal (Lisbon), South Korea (Gunpo-si), and Malaysia (Shah Alam), with operational references in Thailand, Vietnam, Turkey, and Australia. Self-reported scale metrics include 24+ years of regulatory experience, 3,400+ completed projects, 94% customer satisfaction, and 300+ positive feedback signals on its template products. The company is privately held with no disclosed external funding or institutional investors.

Name

I3cglobal

Legal name

I3CGLOBAL

Website

https://i3cglobal.com

Company type

Private

Founded year

2010

Operating status

Operating

Headcount range

51–100 employees

Short description

I3CGlobal is a Bangalore-headquartered regulatory consulting firm that helps medical device and IVD manufacturers achieve compliance with EU MDR/IVDR CE Marking, US FDA 510(k), UKCA, and ISO 13485, operating from seven offices globally with 51-100 employees and 3,400+ completed projects.

Ownership category

akta.pro rank

Product category

Medical Device Regulatory Consulting

NAICS

Testing Laboratories and Services (541380)

SIC

Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Inspection Readiness & Regulatory Authority Support (FDA/EMA/MHRA) (HLAGAKAF)

akta.pro secondary industries

Regulatory Affairs, Labeling & Advertising/Promotion Compliance (HLAJADAI), Conformity Assessment, Testing, Inspection & Certification Cooperation (BPADANAD)

Keywords

• Medical device regulatory consulting
• EU MDR compliance services
• FDA 510(k) consulting
• IVDR CE marking services
• ISO 13485 certification

Headquarters

HQ city

Bangalore

HQ country

India

HQ region

Asia

Offices7 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Technology or R&D, Marketing or Sales, Infrastructure

Revenue model

1. EU MDR/IVDR CE Marking Consulting Services: Comprehensive regulatory consulting for CE Marking under EU MDR 2017/745 and EU IVDR 2017/746, including technical documentation preparation, Notified Body coordination, performance evaluation, clinical evaluation report, and post-market surveillance support. Revenue is project-based, varying by device risk class, models, and variants.
2. FDA 510(k) and Registration Consulting: Regulatory consulting for FDA 510(k) premarket notification, De Novo submission, US FDA registration for drugs, medical devices, food, and cosmetics, QMSR, MDSAP, and US FDA Agent services. Pricing is project-based and publicly listed by service category.
3. EU Authorized Representative (EAR) and UK Responsible Person (UKRP) Services: Annual retained services acting as legal EU Authorized Representative and UK Responsible Person for non-EU/UK manufacturers. Includes EUDAMED registration, SRN application, UDI/Basic UDI-DI registration, and compliance support. Billed annually.
4. ISO 13485 Certification Consulting: Consulting support for EN ISO 13485:2016 quality management system certification for medical device manufacturers.
5. MDR Technical File Templates (Product Sales): Sale of pre-built Microsoft Word technical file templates for MDR compliance, priced by risk class (Class I: $400-$500, Class IIa: $500-$600, Class IIb: $600-$700, Class III: $700-$800, Special Rule devices: $700-$1,200). One-time license fee per template.
6. MDR Procedure Templates (Product Sales): Sale of editable Microsoft Word procedure templates for MDR compliance. Priced at $100-$200 per document. One-time license fee.
7. GSPR Checklist Template (Product Sales): MDR GSPR Checklist Template (Document ID: MDR-GSPR-01) sold for $300. One-time purchase.
8. 21 CFR 111 GMP Implementation and FDA Inspection Support: 21 CFR Part 111 CGMP implementation for dietary supplement manufacturers, pre-FDA inspection support (onsite or remote), and post-inspection 483 closure. Implementation starting at $7,000, pre-inspection at $1,000/man-day, 483 closure at $2,000/483 parts.

Pricing tiers

Go-to-market motion1 record

Distribution channels3 records

Marketing channels5 records

Core offering

I3CGlobal provides regulatory consulting and technical documentation services for medical device and in vitro diagnostic (IVD) manufacturers seeking CE Marking under EU MDR/IVDR, FDA 510(k) clearance, UKCA Marking, and ISO 13485 certification. The firm also serves as legal EU Authorized Representative (EAR) and UK Responsible Person (UKRP) for non-EU/non-UK manufacturers, and sells downloadable Microsoft Word technical file and GSPR checklist templates.

Product overview

I3CGlobal is a life sciences regulatory consulting company offering a comprehensive portfolio of regulatory compliance services for medical device and in vitro diagnostic manufacturers seeking market access in the EU, USA, and UK. The core service portfolio centers on EU MDR/CE Marking Services, EU IVDR/CE Marking Services, FDA 510(k) Consulting, and ISO 13485 Certification, supported by specialized consulting services including Technical Documentation, Clinical Evaluation Reports (CER), Post-Market Surveillance (PMS), Risk Management, and Biocompatibility Testing. The company also provides legal representation through EU Authorized Representative (EAR) and UK Responsible Person (UKRP) services, enabling non-EU/non-UK manufacturers to place devices in these markets. I3CGlobal offers supplementary template products including MDR Technical File Templates and GSPR Checklist Templates, priced by device class and complexity. The company operates cloud-based documentation systems with 24/7 uptime guarantee and maintains ISO 27001 data security certification.

Differentiator

Problem solved

Functional benefit

Products and services

• EU MDR/CE Marking Services
• EU IVDR/CE Marking Services
• FDA 510(k) Consulting
• ISO 13485 Certification Consulting
• EU Authorized Representative (EAR/EC REP)
• UK Responsible Person (UKRP)
• UKCA Mark Certification Consulting
• US FDA Registration Services
• EUDAMED Registration
• Drug Master File (DMF) Services
• 21 CFR Part 111 Consulting
• US FDA QMSR Consulting
• MDSAP Audit Support
• Biocompatibility Testing Services
• Software CE Marking Consulting
• MDR Technical File Templates
• GSPR Checklist Template
• MDR 2017/745 Procedure Templates

Quantifiable outcome

• 3400+ Completed Projects across medical device regulatory consulting
• +2 more outcomes

Segments5 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature5 records

Partnerships

Two partnerships are on record, tiered core.

• IQZYME Medtech Private LimitedcoreStrategic or Co-development Partner · 21 October 2025I3CGLOBAL expanded its IVDR consultancy services globally with additional expertise from a new collaboration with IQZYME Medtech Private Limited. The collaboration brings specialized expertise to support in vitro diagnostic manufacturers in achieving CE Marking compliance under EU IVDR 2017/746, including technical documentation review, performance study planning, and Notified Body coordination.
• Reghelps SRC CROcoreStrategic or Co-development Partner · 13 October 2025I3CGlobal announced a strategic collaboration with Reghelps SRC CRO to provide comprehensive IVD Performance Evaluation services in India, supporting CE Marking compliance under EU IVDR regulation. The partnership combines I3CGlobal's regulatory expertise with Reghelps SRC CRO's clinical research capabilities to streamline the IVD certification process for manufacturers.

Scale indicators6 records

Recent moves7 records

Expansion highlights6 records

Direct peers

• Maetrics: Life sciences regulatory and quality compliance consultancy serving medical device and pharma clients; comparable to I3CGlobal on EU MDR consulting, QMS implementation, and Authorized Representative services.
• Freyr Solutions: India- and US-headquartered regulatory services firm covering EU MDR/IVDR, FDA, and emerging markets for medical devices, cosmetics, and pharma; directly competes with I3CGlobal on cross-border regulatory outsourcing.
• Emergo by UL (UL Solutions): Global medical device and IVD regulatory consulting and Authorized Representative services; closely overlaps I3CGlobal across EU MDR/IVDR, FDA, and UKCA work and is the most direct comparable peer.
• Qserve Group: European medical device regulatory and quality consulting firm with strong MDR/IVDR expertise; competes with I3CGlobal for EU-focused technical documentation and Notified Body support work.
• RQM+ (formerly R&Q): US-based regulatory and quality consulting firm focused on medical device and IVD manufacturers; overlaps with I3CGlobal on technical documentation, CER/PER, QMS, and FDA submission support.

Emerging players

• RegDesk: Smaller, India-influenced medical device regulatory services firm offering EU, US, and Asia-Pacific submissions; an emerging player that competes on price-sensitive regulatory documentation work.

Broad incumbents

• TÜV SÜD: Global certification and testing organization with medical device Notified Body designation; comparable on ISO 13485 certification and EU MDR/IVDR technical file review, though its scope is far broader than I3CGlobal's.
• NSF International: Large global public health and safety organization offering medical device testing, certification, and regulatory consulting; a broad incumbent whose services overlap I3CGlobal's ISO 13485, biocompatibility, and regulatory representation offerings.
• BSI Group: UK-based standards and certification body that is a designated EU Notified Body for medical devices; provides ISO 13485 certification and regulatory consulting that overlaps with I3CGlobal's UKCA and EU MDR services.
• DEKRA: Global testing, inspection, and certification body with a medical device practice including Notified Body services; competes with I3CGlobal on certification-driven engagements but operates a much broader portfolio.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks7 records

Key highlights7 records

Customer concentration

Compliance3 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles3 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about I3cglobal