• FDA Agent


    The appointment of an agent is a mandatory requirement for any foreign company wishing to market their products within the United States. FDAbasics can act as your FDA agent, as well as offering a suite of regulatory compliance services to help you through the FDA registration process and other FDA compliance services.

  • drug registration


    With a track record in supporting companies through the drug approval process, we offer consulting services for FDA drugs and pharmaceuticals compliance. This includes assistance for IND, NDA, ANDA, NADA,  ANADA   Establishment registration, OTC drug product listing, NDC number, SPL authoring , self-identification GMP compliance, as well as other regulatory compliance related to drugs.

  • FDA medical device registration


    We offer regulatory compliance services to Class I and Class II medical devices. Our services include assistance with Establishment registration and device listing, GDUID, 510(k) (Premarket Notification), PMA (Premarket Approval), De Novo (Evaluation of Automatic Class III Designation), and HDE (Humanitarian Device Exemption).

  • FDA food registration

    Food/Dietary Supplement

    Our FDA consultancy can deliver support to enable you to market your food and dietary supplements. We can provide complete assistance for  understanding FDA requirements  for  your products, facility registration, Process Filing for Acidified and Low-Acid Canned Foods (SID), food and dietary supplement labelling review, and FSVP related services.

  • cosmetic labelling requirements


    We provide VCRP assistance, as well as design and labeling review services, to help you comply with the FDA's labeling requirements for cosmetics companies.

  • FDA Registration

    FDA Registration is a mandatory requirement to sell your Food, Drug, and medical device in the United States.  We help you to understand the FDA requirements and assist you in complying with FDA registration requirements.


FDA US Agent and Regulatory Compliance Services

FDAbasics  LLC is an experienced US FDA  consulting firm, with an established base of global built over the last twenty years.

Our expertise spans the breadth of compliance services required to market FDA-regulated products, including food, dietary supplement labeling, drugs, medical devices, and cosmetic labeling. We are a leading service provider of  US Agent for FDA-regulated industries and a US agent for drug companies. We offer complete assistance to meet FDA regulatory compliance requirements.

Our services for drug companies include U.S Agent service, Assistance for ANDA submission process, IND, NDA, NADA and drug registration, NDC number, listing services self-identification, eCTD publishing services  & complete assistance to meet FDA requirements. For food and dietary supplement companies, we offer U.S Agent, FSVP agent, Registration, Labeling review, FSVP assistance, FDA SID numberfood facility registration services, and other FDA compliance services. For medical devices, we offer U.S Agent services, FDA registration, and listing, as well as UID submission, medical device registration services, and other services for device approval.

In the past 20 years, we have developed experience and understanding of the knowledge and skills needed to address a wide variety of regulatory issues. This means that we can offer solutions that add value, saving you both money and time. We believe in a transparent approach to business, and always put our customers at the center of our work. We strive to achieve excellent customer satisfaction through superior services.

We offer the lowest guaranteed fees for quality services. Our charges are disclosed upfront, and there are no hidden costs or increased annual fees.

FDAbasics LLC is one of the top  FDA consultants and US Agent service providers. You can see our reviews on Trustpilot and Google.

Why Choose Us ?

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  • Over twenty years of experience.
  • Integrated regulatory solutions with core technical assistance.
  • Consulting services that consider your business and compliance requirements.
  • Cost-effective pricing and high-quality services.
  • Free guidance on basic regulatory compliance.
  • Committed to customer confidentiality
  • Fast and reliable  FDA  compliance solutions
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Perfect Service for FDA registration

Perfect Service for FDA GDUFA self identification and Establishment Registration for foreign Companies. Prompt and round the clock Response
Nadine from Switzerland – Review on Trustpilot
quick response, flexible attitude, reasonable price
Ayako Fukushima from Japan on
  I was trying to work with a different company to have labels reviewed and not only were they expensive but rarely returned my messages. I was so glad to find Rush at FDAbasics. The prices were reasonable Rush quickly returned everyone of my messages with complete and thorough information. Truly they were among the best organizations I have dealt with in starting up a new business.
Carol from Canada – Review from
I was very happy with FDAbasics’s service and would definitely recommend them! I had reached out to few other companies to get a quote on fees and turnaround time to assist our company and FDAbasics went over and above for us so it was a no brainer for us who we decided to move forward with. Very satisfied.
Thank you!
Anita from Canada on TrustPilot

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