DRUG ESTABLISHMENT REGISTRATION


This is not FDA Website. We are consultants and USFDA Agents helping manufactures and Exporters across the globe to register and List the products with US FDA.

Readers are requested to read more about USFDA Drug Registration and Listing regulation before starting the activities.

We provide service for the following category of Products

  • OTC Drugs [ Those Drug molecules listed in the OTC monograph are only considered]
  • API Manufactures [ all kind of pharma API’s included]
  • Homeopathic [ All kind of homeopathic medicines]
  • Testing Laboratories [ Laboratories testing OTC and Generic Drug products for Human and Clinical trial purpose]
  • Medicated Lotions, Creams and other external preparation [ considered as cosmetics in various countries]

Important


Your Drug Establishment / Facility must have atleast one Listing to keep Registration and NDC Number / Labeller Code active.

The below table explains each of the steps one by one.

Steps

Activity

Fees

01

Submit Filled Application Form online

NA

Need Expert  Guidance ?

150 USD

02

US Agent fees for the initial year

600 USD

03

Verification of DUNS Data  

FREE

04

Drug Establishment Registration

100  USD

05

NDC Number / Labeller Code Request

06

SPL Preparation and Submission

07

Verify Registration Status with US FDA

NA

08

Submit Labels of every dosage form

NA

Need our expert assistance ?

650 USD

09

Submit Application for Drug Listing

400 USD

Need our expert assistance

50 USD

10

Verify your Listing Details

NA

Payments made from USA

Drug Registration & Listing

Payments made from INDIA

Drug Registration & Listing

Payments made from Other Countries

Drug Registration & Listing

BILLING / PAYMENT assistance write to accounts@i3cglobal.com

 

Frequently asked Questions


1. What you mean by expert guidance? For how long?
Experts from our company will understand your product, guide you correctly considering all the possible errors which can happen during filling. Our support ends with successful submission of Application Form till registration is completed.

2. Do I need to pay for all stages at a time?
NO. You can make payments stage by stage ( for example; make payment for Stage 02 once stage 01 is completed and you are satisfied with our service.

3. What you mean by stage 2 optional service?
Your product label should comply with FDA regulation for sure!, but you can try getting the guidance from other reliable sources. In case you need to our expert service you need to buy this service.

4. How Medicated Lotions, Creams and other external preparation  comes under Drugs as per US Regulation?
If any of the above contains Medicines as one of the major active ingredient, it is as Drug not a cosmetic technically,  so drug establishment registration and Listing is mandatory.


More information http://www.fda.gov/

INDIA – Bangalore
+ 91 994 591 2081
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USA – Chicago
+1 630 696 1293
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GERMANY – Bremen
+49 2161 990 8831
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