FDA Liaison
For our non-U.S. clients or those who do not have extensive regulatory affairs departments, Swiftwater Group provides FDA representation as an agent (non-U.S. companies) or as the regulatory liaison for all communications and submissions with FDA.

Regulatory Strategy Development
Often our clients have a product for which the regulatory path is unclear. Swiftwater Group provides assistance in reviewing the product, selecting appropriate indications, and evaluating other contributing factors to help our clients develop the optimal regulatory strategy.

Preparation of Regulatory Submissions
Swiftwater Group can independently prepare all regulatory documents on behalf of our clients:
Regulatory Operation Services
As a follow-on service to developing a regulatory strategy, Swiftwater Group can integrate into the client’s organization and provide the necessary regulatory expertise throughout the product development process. This, in essence, is the combination of all the previously described regulatory services into one turnkey offering.