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.KNOW MORE
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.KNOW MORE
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).KNOW MORE
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.KNOW MORE
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.KNOW MORE
FDAbasics offers a range of other regulatory consulting services, including quality system compliance, vendor audits, and managing the quality agreement with your contract manufacturer. We can help with all FDA compliance related services.KNOW MORE
FDAbasics LLC is an experienced provider of FDA regulatory consulting services, with an established base of global otc drug listing 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 recognized US agent for FDA regulated industries or US agent for drug companies. We offer complete assistance to meet FDA regulatory requirements.
Our services for drug companies include U.S Agent service, Assistance for ANDA submission process, IND, NDA, NADA and drug registration, listing services self-identification, & complete assistance to meet FDA requirement. For food and dietary supplement companies, we offer U.S Agent, FSVP agent, Registration, Labeling review, FSVP assistance, FDA SID number, NDC number, food 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.
Nadine from Switzerland – Review on TrustpilotPerfect Service for FDA GDUFA self identification and Establishment Registration for foreign Companies. Prompt and round the clock Response
Ayako Fukushima from Japan on Trustpilot.comquick response, flexible attitude, reasonable price
Carol from Canada – Review from Yelp.comI 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.
Anita from Canada on TrustPilotI 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!