Program Strategy
- Program Strategy
  We provide comprehensive services to guide you through the development and execution of a program strategy, across all stages of development and life cycle management, for drugs, biologics, and medical devices.
  Overview
Clinical Trials
- Clinical Trials
  Through decades of focused therapeutic expertise, strong site and investigator relationships and an insider’s understanding of the regulatory landscape, Rho’s team of experts ensure consistent trials—traditional, virtual, and hybrid—that run smarter and more efficiently.
Marketing Applications
- Marketing Applications
  Marketing application submissions, including NDAs, BLAs, and MAAs, are the culmination of years of research and the final hurdle before a product makes it to market. Let our integrated team of experts get your product across the finish line.
  Overview
Why Rho
- Why Rho
Resources
- Resources
Careers
- Careers

Success Story

Preparation and Expertise Result in Successful Advisory Committee Meeting for Analgesia Product

Situation: NDA submission and an FDA Advisory Committee meeting for a pain and addiction product

The Success: We supported a client’s successful FDA Advisory Committee Meeting regarding a pain/addiction product for which we prepared the entire NDA submission. To assist the client with their meeting, we:

Created more than 100 new displays to support core and backup slides
Proposed a new ad hoc analysis which was used in the core presentation and directly addressed some FDA concerns
Provided on-demand analyses leading up to and during the meeting

For the 4 questions posed, the Advisory Committee gave a majority favorable finding for all of them. There was also a formal discussion point regarding potentially critical application deficiencies, and the Advisory Committee deemed all of them not-critical.