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
  Our global solutions leverage decades of focused therapeutic expertise, strong site and investigator relationships and an insider’s understanding of international regulatory landscapes. Rho’s global 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
Government Partnerships
Why Rho
- Why Rho
Resources
- Resources
Careers
- Careers

White paper

Accelerated Approval with Inadequate CMC Program Development

This white paper examines the development and marketing application review processes for the chemistry, manufacturing, and controls (CMC) aspects of products targeting serious conditions in the context of the FDA’s expedited accelerated approval (AA) and breakthrough therapy designation (BTD) programs.