Auric Strategies Consulting Services

User fee negotiations are a powerful tool for industry to advance key priorities, however, experience in the process is critical to success. Stephen’s experience in FDA user fee negotiations is unparalleled. He has been on both sides of the table - representing FDA in PDUFA IV and supporting the prescription drug industry in PDUFA V, VI, and VII.  He has also consulted for industry on the biosimilar (BsUFA), generic drug (GDUFA), and animal drug (ADUFA) user fee programs.

Assist companies with their efforts to shape the future state and drive change in the regulatory landscape.

Whether its responding to Draft Guidances or Congressional Requests for Information, AuRIC Strategies guides you through the process from concept to publication.

Congress can be an effective tool to impact the regulatory environment.  AuRIC Strategies can help turn policy into legislative solutions.

Crafting and presenting materials for internal and external audiences to explain regulatory issues

Conducting benchmarking and landscape assessments for policy issues impacting the industry, global regulators, and other stakeholders.