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Services

FDA Agent

US Agent

  • PForeign Drug, Food, and Medical Device companies
  • PComplex IND and ANDA application
  • PFree registration assistance
  • PLowest fee with 15 years of trust
FDA food registration

Food and Dietary Supplement

  • PUS Agent & FDA registration
  • PLabeling review
  • PFSVP compliance
  • PSID number
FDA medical device registration

Medical Device

  • PUS Agent for foreign companies
  • PRegistration & Listing assistance
  • PImporter registration
  • P510 clearance
drug registration

Drugs

  • POTC, Homeopathic and Prescription drugs
  • PRegistration and NDC Listing
  • PIND, ANDA, DMF filing
  • PeCTD and Controlled correspondence
cosmetic labelling requirements

Cosmetics

  • PVCRP registration
  • PCosmetic labeling review
cosmetic labelling requirements

Other Services

  • PGeneral regulatory consulting
  • PGlobal regulatory compliance
  • PPharmacy compliance
regulatory compliance services

FDAUS Agent& 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 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.

FDAbasics LLC is one of the top  FDA consultants and US Agent service providers. Our reviews on Trustpilot and Google speak for themselves.

Why Choose Us?

  • POver twenty years of experience.
  • PIntegrated regulatory solutions with core technical assistance.
  • PConsulting services that consider your business and compliance requirements.
  • PCost-effective pricing and high-quality services.
  • PFree guidance on basic regulatory compliance.
  • PCommitted to customer confidentiality
  • PFast and reliable FDA compliance solutions READ MORE

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Additional ResourcesHeading

Learn by Watching

We understand sometimes reading is painful, so we have made it easy with explanatory videos for regulatory requirements.

Free Tools

We have created  self-assessment forms for you to understand the FDA requirements. Click here to explore. 

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