Market in the United States: FDA registration
If your company is interested in selling products in the United States, we have the ideal solution. Check below all the services we perform for this market.
Product Registration in the United States of America
Passarini Regulatory Affairs has a team of experts trained in a variety of matters related to consultancy and assistance with the FDA. Our specialists have already conducted several processes with the FDA and are able to provide the best service so that your company can market its products in the United States of America.
See below some of the services included in our portfolio:
- Product Classification based on FDA criteria;
- Survey on the existence of a similar product registered to analyze the possibility of elaborating a 510K process;
- Survey of all regulations applicable to the product;
- Comparative analysis of the product with the similar product already registered;
- Submission of the process for protocol with the FDA.
Product registration with the FDA has no expiration date and will be maintained as long as the company pays the annual product renewal fee.
