Project Description

  • Banner for FDA Approval

FDA Approval With Passarini

What is FDA Approval?

When a product is termed as FDA approved in the US, it means that data on the product’s effects have been reviewed by CDER, and the drug is determined to provide benefits that outweigh its known and potential risks for the intended population.

USA Commercialization and FDA Approval:

If your company is interested in USA commercialization and getting your products FDA approved, we have the ideal solution. Check all the services we provide for this market below.

1. USA Product and FDA Registration

Passarini Regulatory Affairs division has a team of specialists trained in a variety of issues related to consulting and advising for the FDA. Our specialists have already conducted several processes with the FDA and are able to provide the best service to help you get FDA registration to market your products in the United States of America.

Some of the services in our portfolio include:

  • Product Classification based on FDA criteria
  • Identifying whether there is a similar product registered to determine the possibility of preparing for the 510K process
  • Determining all regulations applicable to your product
  • Comparative analysis of the product with any similar product already registered
  • Sending the process for protocol with the FDA.

Once your product passes the FDA registration process, the certification has no expiration date and will be maintained as long as the company pays the annual fee for the renewal of the product.

2. USA Regulation

  • Market Analysis – USA Sanitary Regulations
  • Audits and Quality System
  • 510 k approved

Learn more about our FDA approval consulting and regulatory advisory services by contacting us today. 


Other services you may be interested in: 

> Quality Management Systems

> INMETRO Certification

> ANATEL Certification

> ANVISA Notification and Records

> International Licences

> Risk Assessment

> CE Bookmark



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