FDA 21 CFR 111 (GMP for Dietary Suppliment Manufactures)


 The following services we provide for manufactures and exports to comply with USFDA Food Regulations. We deliver the services from our USA and INDIA location to our worldwide customers.

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Activity

Fees

1

Facility GAP Analysis

500 USD /man-day  + Travel + Lodging + GST
(with report based on 21 CFR 111)

2

Consultation for Closing the GAPS identified in GAP Analysis

400 USD /man-day  + Travel + Lodging

3

Drafting of Quality Manual,
Drafting of Mandatory Procedures
and Templets

1200 USD  (Offline work in 20 days)

4

Label Review

699 USD / Label

5

US Agent Service

399 USD / year

6

GMP Food Facility Design

Refer Below Link
https://www.i3cglobal.com/fees/MANUFACTURING-FACILITY-DESIGN-fee.html

7

US FDA Pre Audit GAP Analysis

750 USD/man-day  + Travel + Lodging

8

US FDA Post Audit 483 Response preparation

750 USD  /man-day  + Travel + Lodging

9

483 Closing Support

600 USD /483’s + Travel + Lodging

To initiate a project we need a minimum business value. The business value is calculated from the client location to our nearest location.

Additional clarification please write to us.


INDIA – Bangalore
+ 91 994 591 2081
Phone / Viber / WhatsApp


USA – Chicago
+1 630 696 1293
Phone / Viber / WhatsApp


GERMANY – Bremen
+49 2161 990 8831
Phone / Viber / WhatsApp


mail enquiry@i3cglobal.com
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