This document provides an overview of the services offered by i3 Consultants related to FDA regulatory compliance. They offer assistance with 510(k) submissions for medical devices, food labeling reviews for acidified and low-acid canned foods, dietary supplement registration and labeling, US Drug Master File submissions and maintenance, drug establishment registration, and food manufacturing establishment registration and process filing. Clients can contact i3 Consultants for more information on these FDA regulatory services.

1. www.i-3-c.com
USA - INDIA

2. Scope of i3 Consultants
 Labeling Review
FDA (510k)  Acidified food
 Low-acid canned food
 Identification of device class, product code
 Review the product Labeling
 Identification of regulation number
 Prior Notice
 Identification of predicate device
 Find out if the use appropriately regulated indirect
 Identification of test requirements
additive.
 Identification testing lab
 Find out if the use of the component is Prior Sanctioned.
 Preparation of 510( k ) documents
 Find out if the use of the component is generally
 Submission of 510(k) document to FDA
recognized as Safe.
 Communicate to FDA on behalf of our client  Submit a Threshold of Regulation Exemption Request.
 Prepare clarifications to questions from FDA  Submit a Food Contact Formulation (FCF) Notification
 Assistance in transfer of payment to FDA
 Assistance in Establishment registration with FDA
 Assistance in Device Listing with FDA
Dietary supplement
 Register your establishment with FDA
 Review the product labeling
US Drug Master Filing  Provide US Agent Service
 Identification of test requirement (for type II DMF and III
DMF).
 Identification of testing lab (for type II DMF and III DMF).
Drug Establishment Registration
 Edit and organize DMF information.  Register your establishment with FDA
 Submitting DMF to FDA.  Review the product Labeling
 Communicating with FDA on behalf of our client.  Communicating with FDA on behalf of our client.
 Assisting clients to issue LOA (letter of authorization)  Labeling Review
 Assistance with DMF Annual report submission to FDA.
 Assistance in DMF Closure request submission to FDA.
 Assistance in DMF Reactivation request submission to
FDA. (for closed DMF) Contact us for more information
Call + 91 99 80 5064 8432
Or
Mail to: projects@i-3-c.com
Food Manufactures
 Food Canning Establishment Registration
 Process Filing