US FDA approval advantages for pharma companies in another country

Sun. 9 May 2021

In this article, we will try to elaborate on a few tips for new pharmaceutical companies, small pharma companies, and biopharmaceutical companies in other countries to understand the US FDA approval advantages. Also, we will discuss the importance of the FDA for their new drugs and expanding their pharmaceutical business in the pharmaceutical sector (pharma sector).

Now let’s discuss “What is the FDA?”

These letters are an abbreviation for Food and Drug Administration. To explain, this organization is under the auspices of the United States Department of Health. To summarize, FDA is responsible for reviewing the status of all products in the following four areas:

  • Food and beverage
  • cosmetic products
  • Medical Equipment
  • Medicines (pharmaceutical drugs, biopharmaceuticals)

Also, you may want to know, “What are the powers and responsibilities of this organization?”

  • Any manufacturer wishing to sell or export such products to the United States must obtain a set of related licenses and approvals from the FDA (US FDA approval advantages).
  • This organization must approve any new drug to be sold.
  • Having the FDA approval certificates helps companies market and sell the product.

What are the benefits of obtaining FDA certification (US FDA approval advantages)?

  • Registered in the list of FDA-approved companies
  • View company profile by other traders (importers and exporters) and investors around the world
  • Find an FDA-approved business partner for export, import, or joint venture
  • Review and analyze product composition in the most prestigious FDA laboratories and compare with strict US standards
  • Smoothing the export route to the United States and other countries
  • Periodically receive the latest scientific findings in the relevant industry
  • Access to FDA scientific resources
  • Ability to ask scientific questions and get answers

Services that can be provided

  • FDA Registration and Annual Renewal (FDA Registration)
  • Appoint a representative in the United States for communication between the two parties
  • Certificate presentation
  • Review of product combinations and product labels and comparison with US standards (Label & Ingredient Review)
  • Registration of products and specifications for export to the United States at the US Customs and Protection Organization (FDA Prior Notice)

How to provide services

  • Obtain sufficient information and necessary guidance in any way regarding the most suitable services for each company
  • Appointing a management representative to contact the country Coordination Office
  • The official announcement of the requested services by the applicant
  • Transfer of the application to the FDA by the country office
  • Transfer of relevant forms to be completed by the applicant company
  • Completing the forms and transferring them to the country office
  • Signing a contract between the applicant company and the country Coordination Office
  • Deposit fees (the currency of the country)
  • Send documents and costs to the FDA
  • FDA review of documents
  • Perform the requested items and submit the certificate within a specified period


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