Service Request & Fees - iraomega.com

U.S Agent for Domestic and Foreign Food/Cosmetics Establishments ($150)

Hazard Analysis and Risk-Based Preventive Control (HARPC) Plan (starting at $2,295)

Hazard Analysis and Critical Control Points (HACCP) Plan (starting at $2,295)

Export Certificate ($295/each)

FOOD

FDA Food Facility Registration and Renewal ($700)

FDA Food Labeling Compliance Review Services ($700)

FDA Dietary Supplement Labeling Consulting starting( $2995) include:

FSVP Agent (contact IRAOmega for Pricing)

Juice Importer Verification Program (starting at $2,295)

Recall Plan ($495)

Food Defense plan (starting at $2,295)

Prior Notice Filing ($25/each)

LACF FoodS

Food Canning Establishment (FCE) and Process Filings (SID) Service (starting at $2,295)

LACF Foods Labeling Compliance Review Services ($700)

Color Additive and Color Batch Certification ($494/color)

Food Contact Substance Review ($1,695/product)

Mock FDA Food Facility Inspection (contact IRAOmega for pricing)

COSMETICS

Registration of Cosmetic Establishment (VCRP) ($495)

Cosmetic Product Ingredient Statement Filing (CPIS) ($495)

California Safe Cosmetics Program (CSCP) Requirement Assistance ($295)

FDA Cosmetic Labeling Review ($695)

MEDICAL DEVICES

Medical Device U.S FDA Agent ($1495 annually)

FDA Medical Device Registration and Renewal ($495)

Device Listings ($495/code)

Pre-Market Notification (510K) (Contact IRAOmega for pricing)

UDIs Submission to GUDID ($145/submission)

EMDR (Contact IRAOmega for pricing)

Denovo submission (Contact IRAOmega for pricing)

DRUGS

U.S FDA Drug Establishment Registration Services and Renewal ($1,295)

IND and NDA Filing Assistance (Contact IRAOmega for Pricing)

Generic Drug Application – ANDA Submission (Contact IRAOmega for Pricing)

FDA Drug Listing and NDC Number Registration Services ($1,295/listing)

No changes Certification of Product Listing ($495 each)

ECTD Publishing Service (Contact IRAOmega for Pricing)

FDA DMF Filing (Contact IRAOmega for Pricing)

U.S Adverse Event Contact for OTC labels ($600)

Registration and Registrant Contact for Outsourcing Facilities ($2,295)

Self-Identification for Generic Drugs Establishment Submission ($1,595)