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Company Overview

Home Our Company
Who-We-Are

Who We Are

Our firm is here to advise and support you on a wide range of regulatory documentation and cGMP advisory solutions.

Mission

Our Mission

Our mission is to interpret and understand standard requirements, find new ways and build new strategies to overcome the possible questions from regulatory authorities.

Our Vision

Our Vision

To emerge as a leading regulatory consulting company by endorsements from existing satisfied customers. We consider this as our biggest testament.

COMPANY OVERVIEW

Providing the Best Regulatory Solution with
Quality Assurance & Data Security

US FDA Approval

We Have More Than 20+ Years Practical Experience

“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.”

 

Our Core values shape the culture of our organization and define the character of our company

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20
YEARS Of
Experience
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54
Professional
Experts
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3530
Successful
Projects
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1200
Satisfied
customers

Previous year (2021-22) projects and achievements

CE Marking 18 Projects 11 Completed

US FDA 510k 25 Projects 13 Completed

EN ISO 13485:2016 17 Projects 11 Completed

21 CFR 820 12 Projects 10 Completed

21 CFR 211 04 Projects 04 Completed

21 CFR 111 03 Projects 03 Completed

MDSAP 01 Projects 01 Completed

USFDA DMF 12 Projects 12 Completed

FDA Medical Device Registration 33 Projects 33 Completed

FDA Drug Establishment Registration 43 Projects 43 Completed

FDA Food Establishment Registration 132 Projects 132 Completed

FDA Cosmetic Registration 09 Projects 09 Completed

SOME OF OUR CLIENTS

We Appreciate Clients

US FDA Approval
essilor
Medtron
Pepsi
Boston scientific
Bjain Pharma
Patanjali
Aditya Birla Group
lilly
Saint Gobain
Philips
Intersystems
Healthium
Bio Systems
Braun
Baxter

Our Team

I3CGLOBAL is a global sustainability partner for top corporate, medium, and small-scale healthcare product producers. We are a major regulatory service supplier for the EU MDR / IVDR, and UKCA, as well as US FDA Compliance for Healthcare product manufacturers. I3CGLOBAL was founded in the year 2000to and become the go-to sustainability partner for “all” wishing to launch healthcare products from other countries in the United States and Europe. I3CGLOBAL has a highly experienced and competent team located among our offices in Germany, India, the United Kingdom, and the United States.

 

The majority of new customers are referred to I3CGLOBAL by existing customers and their employees. Here are kind words from a few of our satisfied customers about their experience with us during their journey to success.

Certificates

I3CGLOBAL REGHELPS PRIVATE LIMITED QRO UKAF 27001 2022061080
I3CGLOBAL U