Follow Us:

Home 1 EXCEPTIONAL SERVICE ONE STOP FOR ALL YOUR REGULATORY NEEDS Fully functional service lined up for INDIA, EU & USFDA in one place Home 2 A trustworth company SUSTAINABLE PARTNER for leading corporates, medium and small scale healthcare product manufacturers across the world. FOR EU AND USFDA Home 3 PROVEN PRACTICES IN CLINICAL EVALUATION Our methods and strategies helped many organizations CER documents accepted by multiple Notified Bodies

Know more about I3CGLOBAL

Regulatory Consulting Services

I3CGLOBAL is a vibrant and customer-focused company that provides healthcare product manufacturers across the globe with US, EU & India regulatory consulting services.

I3CGLOBAL insists on honesty, integrity, and fairness in all aspects of our business and expects the same in its relationships with domestic and international customers. This has earned the trust and respect from our existing customers and is acknowledged as the best!!

20+
Years of Experience
1200+
Happy Customers
94%
Satisfaction

What is Special with Us and Why Our Clients Like Us?

Our strong technical team spread in three continents along with their commitments to core values has helped I3CGLOBAL build long-term, value-centric relationships with customers and become one of the best and dependable global US FDA & EU Regulatory Consulting Firm.

new i3cglobal regulatory consultant homepage image 1

EXPERIENCED TECHNICAL CONSULTANTS

We have the largest pool of full-time technical consultants. Any project can be started quickly.

new i3cglobal regulatory consultant homepage image 2

FAIR PRICE & ONTIME DELIVERY

Customers across the globe are attracted to us due to our fixed and fair pricing policy.

new i3cglobal regulatory consultant homepage image 3

DATA SECURITY & CLOUD DOCUMENTATION  

We are certified for ISO 2711 for data security. We work, we maintain and we deliver documents via the cloud with 24 x 7 uptime assurance.

High Quality Regulatory Consulting Services

new i3cglobal regulatory consultant homepage image 9

Regulatory Documentation and Electronic Submissions to regulatory bodies - this process seems simple but it is a highly complex, resource-intensive and time-consuming task. It is always best to leave it to the experts at I3CGLOBAL!

MEDICAL DEVICES

CE Marking according to new Medical Device Regulation (MDR 2017/745) and In-Vitro Diagnostic Regulation (IVDR 2017/746).

US FDA 510k clearance for medium risk and high-risk devices followed by device registration and listing.

DRUGS

US FDA controls the sale of drugs.

All establishments have to register and list the drug products before the sale or import of such products to the United States of America.

The registration is to be followed by Finished drug manufacturers, brand owners, API manufacturers, and drug testing laboratories.

FOOD/FOOD SUPPLEMENTS

The USA Bioterrorism Act directs FDA to take steps to protect the public from any threats via the food supply.

To carry out, the FDA enforces all manufacturers and importers to register their facilities involved in the supply chain.

It also imposes us with the requirement to be given advance notice on shipments of imported food also known as prior notice.

COSMETICS

The Voluntary Cosmetic Registration Program, so-called VCRP regulation is made by the FDA for cosmetic manufacturers and brand owners.

VCRP insists that all ingredients used for cosmetic products must be intimated to the FDA via so-called system called ingredient statement filing.