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
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 goals. We pride ourselves in our success rates and high rating reviews. We have worked with companies from large to small all over the world.
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.
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.
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
COMPLETED CASES
with applied services.
YEARS OF EXPERIENCE
on number of industries.
AWARDS WINNING
on various competitions.
SATISFIED CUSTOMERS
from all around the world.
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.
