Marketing Applications (NDA/BLA/MAA/NDS)

A Higher Standard

Marketing applications and regulatory submissions are the most critical milestones in your clinical research program. Quality applications and submissions can accelerate time to market, get new treatments to patients sooner, maximize your investment and conserve patent life – demanding a partner with an insider’s understanding of the regulatory landscape and a proven track record for success.

At Rho, each deliverable reflects the collaboration of our integrated, cross-functional team of regulatory affairs, clinical operations, data standards, regulatory and medical writing, project management, clinical data management, biostatistics, and programming experts. And with a 100% technical acceptance rate with the FDA, the quality of your submission is never in doubt.