WHY YOU SHOULD CHOOSE IRAOMEGA?

Cost-Effective pricing and High-Quality services

Fast and reliable FDA compliance solutions

Integrated regulatory solutions with core technical assistance

We are a team of experts with excellent reputation

EXPERIENCED ADVISORS IN THE FIELD OF REGULATORY AFFAIRS

We are committed to providing the highest quality consulting services in the areas of food, drugs, medical devices, and cosmetics. Our focus is to meet our client’s short term and long term business

FOOD

  • S. FDA Food Facility Registration for Food Beverage and Dietary Supplements
  • Food Canning Establishment (FCE) and Submission Identifier Number (SID) Filing
  • Labeling and Ingredient Review
  • Color Additive and Color Batch Certification
  • FDA Foreign Supplier Verification Program (FSVP) & Product Safety
  • Lab Testing and USDA Organic Certification

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MEDICAL DEVICE

  • S FDA Medical Devices Registration and FDA Device Listing
  • FDA Medical Devices Labeling Requirements
  • FDA GUDID Submission and UDI Assistance
  • FDA 510 (K) Preparation and Submission Assistance

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COSMETICS

  • FDA Cosmetic Establishment Registration and Product Ingredient Statements Filing (CPIS)
  • California Safe Cosmetics Program (CSCP) Requirement Assistance
  • Cosmetics Labeling and Ingredients FDA Compliance Review Assistance

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DRUGS

  • FDA Drug Establishment Registration and FDA Drug Listing
  • FDA National Drug Code (NDC) Labeler Code
  • FDA OTC Drug Establishment Registration and OTC Drug Listing
  • FDA Drug Labeling and Ingredient Requirement Review Assistance

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CERTIFICATE OF FREE SALE (CFS)

  • Import To the U.S
  • Export From the U.S

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IRAOmega 

At IRAOmega, our mission is to help ensure businesses comply with all U.S Food and Drug Administration (FDA) regulations. We are devoted to assist our clients from the simplest FDA registration to the most complex proceedings of gaining FDA approval.

Our team consists of highly experienced Regulatory Specialists who are knowledgeable and always up to date with new rules and regulations. IRAOmega emphasizes on competency, integrity, and transparency. Wherever your destination is for your products, we will walk with you from beginning to end.

Frequently Asked Questions

  • Owners or operators of places of business (also called establishments or facilities) that are involved in the production and distribution of drugs, food, and medical devices intended for use in the United States are generally required to register annually with the FDA.
  • US Agent appointment is a mandatory requirement for foreign companies to register with the FDA. US Agent acts as a point of contact for the FDA to communicate with foreign companies.
  • Foreign Food, Drugs, and medical devices facilities intended to register with the FDA
  • Foreign applicants for NDA or IND…
  • The US agent acts to communicate between the FDA and the foreign company.
  • All FDA communications on important regulatory information – such as compliance issues, product-related problems, or inspection schedules – will come through the agent, so you should make sure that your chosen agent has a clear understanding of all regulatory compliance matters.
  • Your FDA agent plays a significant role in FDA regulatory matters, which can have a direct impact on your business.
  • We can complete the U.S Agent appointment online process in less than 20 minutes

321
COMPLETED CASES
with applied services.

10
YEARS OF EXPERIENCE
on number of industries.

25
AWARDS WINNING
on various competitions.

280
SATISFIED CUSTOMERS
from all around the world.

LATEST FDA REGISTRATION ARTICLES

IRAOmega is a privately held regulatory assistance company with headquarters in New York, USA. IRAOmega has no affiliation with or endorsement by United States Food and Drug Administration. The certificates issued by IRAOmega are only for the sake of confirmation of FDA registration for your industry partners and are not recognized by United States Food and Drug Administration – FDA.

FDA Drug Color Additives Requirement

FDA Drug Labeling and Ingredient Requirement  Regardless of the manufacturing origin, all of the drugs [...]

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FDA OTC Drug Establishment Registration and OTC Drug Listing

FDA OTC Drugs & OTC Monographs Over-the-counter (OTC) drug products play an increasingly important role [...]

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FDA National Drug Code NDC Labeler Code

FDA National Drug Code NDC The United States’ Drug Listing Act of 1972 requires registered [...]

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FDA Drug Establishment Registration and FDA Drug Listing

FDA Drug Establishment Registration and Drug Listing According to the United States’ Food and Drug [...]

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FDA Cosmetic Color Additives Batch Certification

All cosmetic color ingredients and additives must be FDA approved for their specific intended use [...]

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FDA Cosmetic Labeling Requirements

FDA Cosmetic Labeling Review Proper cosmetic labels and claims are critical to the import and [...]

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California Safe Cosmetics Program CSCP

For all cosmetic products sold in California, the CSCP program requires the manufacturer, packer, and/or [...]

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FDA Cosmetic Registration and Product Ingredient Statements Filing CPIS

FDA Cosmetic Manufacturing Establishment Registration and Cosmetic Product Ingredient Statements (CPIS) Filing Except for cosmetic [...]

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