FDA PRE INSPECTION GAP ANALYSIS
21 CFR 820 / 211/111 COMPLIANCE SUPPORT
FDA 483 RESPONSE
USFDA TECHNICAL CONSULTATION

US FDA Service Fees

Activity

Man-day Fees

GAP Analysis for Food & Neutraceuticals

400 USD for each Man-day

GAP Analysis for Medical Device

500 USD for each Man-day

GAP Analysis for OTC Drugs & Cosmetics

600 USD for each Man-day

Guidance for Initial responce prepration and USFDA submission support

700 USD for 2 Man-days

Support for closing each FDA Observation /483's

350 USD

FDA Pre-Inspection Training

700 USD/Man-day

Travelling & Lodging and local convinence  must be arranged by the client.
Our consultants are located in Germany, India and USA.  The language of communication and documentation is in ENGLISH only.

 

INDIA -Bangalore
+ 91 994 591 2081
Phone / WhatsApp


USA -Chicago
+1 630 696 1293
Phone / WhatsApp


GERMANY-Bremen
+49 2161 990 8831
Phone / WhatsApp

enquiry@i3cglobal.com

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