Welcome to I 3 CONSULTING!

I 3 CONSULTING, leading Global Quality Assurance & Regulatory Consultants & In-Country Representatives (EU & FDA) to healthcare industries to comply with European and US FDA requirements.

Our network of 100+ management and pharma consultants, 10+ testing laboratories, 36+ full time technical consultants, 4+ office locations in different countries and well-wishers from 3600 + satisfied customers makes us one of the most reputed and trusted service provider delivering economic, quality, time bound, solutions to the customers across the globe.

Medical Device

Medical Device

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US FDA REGISTRATION AND LISTING

US FDA REGISTRATION AND LISTING

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USFDA INSPECTION

USFDA INSPECTION

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PRICING

PRICING

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Previous year (2018) projects and achievements

CE Marking (Class IIa, IIb, III) 22 Projects 14 Completed

US FDA 510k (Class II & III) 12 Projects 07 Completed

EN ISO 13485:2016 17 Projects 11 Completed

21 CFR 820 12 Projects 07 Completed

21 CFR 211 04 Projects 04 Completed

21 CFR 111 03 Projects 03 Completed

MDSAP 02 Projects 01 Completed

USFDA DMF 18 Projects 18 Completed

FDA Medical Device Registration 43 Projects 33 Completed

FDA Drug Establishment Registration 48 Projects 38 Completed

FDA Food Establishment Registration 142 Projects 142 Completed

FDA Cosmetic Registration 11 Projects 11 Completed

Navigate Medical Device Consulting for CE Marking, FDA 510K, ISO 13485 & 21 CFR 820

New EU Medical Device Regulation (MDR)

The overall objective of the EU MDR implementation has been to ensure high level of protection of human health and safety.

Classification of Medical Device

How the Medical Device are classified as per new MDR? What are the different class of Medical Devices?

Technical File

The Technical File to be prepared for the Medical Device you are planning for CE Mark. It contains all the information relevant to

Notified Body

Why notified Body is required for CE Certification? How can we contact them and what is the fees ? How can we contact them?

CE Mark Consultants

What is the role of consultant? How they can help you with the CE Certification process. What will be the cost? How consultants selected?

Medical Device Export to USA

US FDA Registration and product listing is mandatory. How and what time the

Clinical Evaluation ( MDR / MEDDEV)

MDR 2017/745, Article 61 and MEDDEV 2.7/1 Rev. 4 Clinical Evaluation and supporting evidences along with report is mandatory for NB.

Testing of Medical Device

All medical products applying for CE Certification has to test the medical device as per Harmonized standards. How and where the test to be conducted? What are the test to be?

Software CE Marking

Software system that has been developed for the purpose of being incorporated into a Medical Device needs CE Logo

ISO 13485:2016

Why Implement ISO 13485 for CE Certification process? How can we implement ISO 13485? How long it will take and what will be the cost?

European (EU) Authorized Representative

An Authorized Representative is the main contact for the European Commission and the National Competent Authorities. It is required for all non european countries.

US FDA 510k

510(k) is a submission made to USFDA to demonstrate that the Medical Device to be marketed is safe and effective as others of similar intended use

21 CFR 820

This is a QMS / GMP requirement and to be implement by all the manufactures based on the product category. How long the process and what will be the cost

Navigate the Drugs, API & Cosmetics Section

GMP Certificate / GMP Implementation

Good Manufacturing Practice (GMP) applicable for all healthcare manufactures. What are the requirements? How a consultant can help?

US FDA Drug Establishment Registration

Those interested to market Finished Formulations, API, Homeopathic Drug, Laboratory Service, should register with US FDA,s Centre for Drug Evaluation and Research.

National Drug Code (NDC Number)

National Drug Code is a ten digit unique product identifier number for human drugs. How to get the number

US FDA Drug Listing

Listing to be done for all drugs planned to sell / Distribute in the United States of America. What is the procedure? How much to cost?

US Agent Service

US FDA enforces the need for foreign-based Food, Drug and Medical Device companies without a location in the United States to register with the FDA after appointing a "U S Agent". How can we contact a US Agent? How much it will cost?

Drug Master File (US DMF)

A Drug master File is a submission to the US FDA that may be used to provide confidential detailed information about facilities, processes or articles used in the manufacturing, processing, packaging and storing of one or more human drugs.

US DMF Submission Fees

Two activities involved are DMF preparation and US Agent Service. We can provide both services for all wishing to have DMF number from FDA.

FDA Drug Label Review

It is the responsibility for the drug manufactures to remain current with the legal requirements for prescription and non-prescription or over-the-counter (OTC) drugs

Establishment Registration & Listing Fees

We are US Agents and consultants provide economic service. Checkout our pricing

Cosmetic Facility Registration(VCRP)

The Voluntary Cosmetic Registration Program (VCRP) is an FDA post-market reporting system for use by manufacturers, packers, and distributors of cosmetic products that are in commercial distribution in the US.

Navigate the Food and Nutraceutical Section

Export of Food to USA

Federal Food, Drug, and Cosmetic Act (FD&C act) and the fair Packaging and Labelling insists manufactures and importers to

Food Establishment Registration Form

All food and nutraceutical exporters has to register with US FDA. Our consulting service helps to comply with FDA bioterrorism act requirements by?

USFDA Food Establishment Registration

(a) Food Manufactures,(b) Food Manufactures & Exporters,(c) Food Exporters and (d) Exporters with Warehouse MUST compulsory register FDA

Food Facility Registration Fees

We offer complete solution for US FDA registration with US Agent service. Low Fees.

FDA QSR 21 CFR 110 / 111 Requirements

Code of Federal Regulations 21 CFR Part 110 requirements for Current good manufacturing practices (GMPs) for food manufactures

FDA Approval

FDA approval depends on the type of product planning to market in the United States.The approvals are limited to scope of products.

Food Additives

A food additive is any substance added to food. directly or indirectly to becoming a component affecting the characteristics of any food

FDA Certificate

Manufactures, Exporters and Traders across the globe are curious to have an FDA CERTIFICATE in the name of the company. But this is not possible. US FDA will not issue any kind of FDA Certificate to any kind of organization

US FDA Food Contact Substance (FCS)

Manufacturers can issue a compliance certificate in compliance with Section 303 c (2) of the Federal Food and Drug Cosmetic act. This section clearly states that penalties are laid down by violation to the act.

 
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