As regulatory and clinical development experts and industry veterans, RRD’s staff is particularly well suited to due diligence and product portfolio assessment.

The Challenge

Our clients, the venture investors on the board of directors of a private specialty pharma company, wanted assurance that each product in the company’s portfolio had well designed clinical trials that would likely yield a definitive outcome.

The Solution

RRD’s senior drug development experts conducted a comprehensive evaluation of the regulatory and clinical program for each of the company’s key drug candidates. RRD provided a favorable recommendation for each of the products under review.

The Result

Since our evaluation was completed, the company has announced favorable Phase 3 results and NDA filing for one program and a favorable Approvable Letter and, subsequent to that, FDA approval for a second product candidate.