Regulatory Strategies

Our experience covers drugs, devices, combination therapies, include some very advanced products such a stem cells. We can file on your behalf or contribute to your ID and IND submissions, managed them through the development process, and finalize the corresponding submissions for clearance or approval (510(k), PMA, NDA).

Based on the target product profile, we assess available regulatory strategies with the goal of minimizing the time and resources needed to reach market, while ensuring that upon approval, the path to rapid market adoption is wide and clear. In parallel, we ensure that the path chosen provides as much product protection as possible, by creating solid barriers to entry for potential competitors.

We have been very successful in many negotiations with regulatory agencies driving new programs through the development process. We also have been called upon many times to help resolve regulatory issues that our clients encountered, such as a clinical hold, and were instrumental in bringing the issue to rapid resolution.