ABOUT

How we do it

​

Whether as a stand-alone service or as part of the product development program, FDA Registration Services delivers expertise on a broad range of regulatory services tailored to meet your exact requirements, using our staff based in our offices in Miami.

Our procedure

FDA Registration Services comprehensive approach will ensure that your product submission is complete and complies with all required elements, reducing the need for costly rework while increasing the probability of a successful submission.

Our simple two-step methodology starts with a process to identify the correct regulatory pathway and establish a clear and well-defined strategy for moving forward to obtain regulatory clearance or approval for your product. We’ll then implement this regulatory strategy and prepare your final submission.

Once you submit, we will provide ongoing support if necessary to respond to FDA questions and address any issues.