The Passarini Regulatory Affairs counts with a team of experts trained in a variety of subjects related to the consultancy and advisory with the FDA. Our specialists have already led several processes along the FDA and are able to provide the best service so that your company can sell their products in the United States of America.
See below some of the services listed in our portfolio:
-
- Product classification based on the FDA criteria;
- Survey about the existence of a similar product recorded for analysis of the possibility of the 510K process elaboration;
- Survey of all applicable normative to the product;
- Comparative analysis of the product with the similar product already registered;
- Send the process for protocol with the FDA.
The record of the product with the FDA has no deadline and will be maintained while the company pays the annual renewal fee of the product.
Contact us for more information about the approval of your product by the FDA.
