ALN provides registrations, listing and consulting services to foreign and domestic companies whose goods fall under FDA and wish to sell in the US market. Whether you are a food, medical device, cosmetic or drug maker, we can assist you with FDA compliance and regulations no matter how simple or complex the matter.

Our team of professionals have over 35 years experience in working with FDA regulated imports.

We come from manufacturing, regulatory, compliance, transportation and supply chain backgrounds and understand the entire process from manufacture to final sale. Let us put our guidance to work for you.

Services we offer you

Whether you are importing Foods, Cosmetics, Medical Devices, Natural Supplements or Pharmaceuticals, we can assist with registrations, product approvals and compliance issues.

Medical devices must meet all FDA requirements prior to being sold in the USA. FDA does not recognize regulatory approvals from foreign countries. Owners or operators involved in the production of medical devices must register their establishments with FDA and pay the user fee on an annual basis.

We offer:

  • US Agent and Device Establishment Registrations
  • 510K Medical Device Listings
  • Medical Device Label Review and Submission
  • Device Color Additives and Batch Certifications
  • DWPE (Detention Without Physical Examination)
  • GUDID and UDI Submissions
  • Medical Device Master Files MAF

Importing cosmetics into the United States can be a very profitable venture for many businesses. It is critical that the cosmetic manufacturer understand and apply the regulations properly to all cosmetic labels, ingredients, marketing and advertising for the products.

We offer:

  • Cosmetic Products Registration and Reporting
  • Cosmetic Labeling and Ingredient Review
  • Color Additives and Color Batch Certifications
  • Cosmetic/Drug Product Registrations
  • DWPE (Detention Without Physical Examination)

FDA regulates all drug products manufactured by both domestic and foreign companies. FDA defines a drug as “articles intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease” and “articles intended to affect the structure or any function of the body of man or other animals.” Any drug claimed to be beneficial for these uses will be regulated as a drug by FDA.

We offer:

  • Drug Establishment Registration and Drug Listing
  • Drug Labeling and Ingredient Review
  • Drug Color Additive and Batch Certifications
  • Drug Master File (DMF)
  • DWPE (Detention Without Physical Examination)
  • FDA Self Identification Requirements

How can we help you?

 Call us directly at 786-246-5285, email us at aneyra@alnchb.com or fill out the form below and we will get back to you: