In cases where companies have a candidate but no infrastructure, RRD has extensive experience assuming broad roles in development to enable a virtual company to go from pre-IND to NDA filing without building an internal team.

The Challenge

As a start up company, our client lacked internal capability to plan and execute a development program for its only product, a drug/medical device combination that would require an NDA. Hiring a team would be expensive, and since the company planned to license the product out to a larger company for commercialization, it wanted to remain as lean as possible.

The Solution

RRD provided a team of development experts with strategic and operational expertise to construct a strategic regulatory and clinical development plan for the company’s product candidate, file the IND, and manage the clinical program. RRD will also prepare the NDA.

The Result

So far, we have helped our client prepare a development plan, prepare and file an IND, and conduct a successful clinical trial. The client is on track to complete the development program through NDA filing in 3.5 years.